Acetaminophen Rectal Suppository

Brand(s)
Acephen, Feverall
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Taro Pharmaceuticals U.S.A., Inc. (2014-09-25)
Oldest Current Product
1982-01-01
License(s)
NDA, ANDA
RxNORM
RECTAL SUPPOSITORY\ACETAMINOPHEN
FDAOB
RECTAL\SUPPOSITORY\ACETAMINOPHEN
SPL Active
RECTAL\SUPPOSITORY\ACETAMINOPHEN
SPL Moiety
RECTAL\SUPPOSITORY\ACETAMINOPHEN

product(s) by strength(s)

acetaminophen 120 mg rectal suppository

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007130118AcephenNDAG&W Laboratories, Inc.1982-01-01ACETAMINOPHENRECTALSUPPOSITORYNDA01806032bbe845-7f0e-c33d-adb2-659f18fedfa9
2516722115FeverallNDATaro Pharmaceuticals U.S.A., Inc.2013-12-12ACETAMINOPHENRECTALSUPPOSITORYNDA018337861e2987-5473-45b0-b2a6-f980a9b0e809

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003630579ANDAWalgreens2010-02-19ACETAMINOPHENRECTALSUPPOSITORYANDA070607f2085b26-5778-4656-8de3-9edd83f914dd
2003630706ANDAWalgreens2010-02-19ACETAMINOPHENRECTALSUPPOSITORYANDA070607daaad04e-4fe8-40ce-9022-1115e9f3a42a
3368000579ANDATop Care (Topco Associates Llc)2011-09-26ACETAMINOPHENRECTALSUPPOSITORYANDA07060772a33640-ca7f-460d-9357-772d5bf56bac
4458020732ANDAPerrigo New York Inc2010-12-14ACETAMINOPHENRECTALSUPPOSITORYANDA07060762b3d354-d7f5-4ba0-b233-ea6be0d7ff03
5597790579ANDACvs2010-01-21ACETAMINOPHENRECTALSUPPOSITORYANDA0706079d89544f-3a66-4f23-b609-381d027e0c95

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1500900001ANDAA-S Medication Solutions Llc2010-12-14ACETAMINOPHENRECTALSUPPOSITORY458020732ANDA070607a9864f73-abb2-4cb1-a692-a48efdeeedf8
2548685624NDAPhysicians Total Care, Inc.2006-06-29ACETAMINOPHENRECTALSUPPOSITORY007130118NDA018060c383bf5b-7043-4f0c-bddb-590aea545859
3687880426ANDAPreferred Pharmaceuticals, Inc.2010-10-28ACETAMINOPHENRECTALSUPPOSITORY458020732ANDA0706076444d200-e32c-4848-80c3-6a23a213fbad

acetaminophen 325 mg rectal suppository

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516722116FeverallNDATaro Pharmaceuticals U.S.A., Inc.2013-12-12ACETAMINOPHENRECTALSUPPOSITORYNDA0183373561bbc3-53b0-4857-8b71-39e165ed95ce

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007130164AcephenANDAG&W Laboratories, Inc.1992-03-27ACETAMINOPHENRECTALSUPPOSITORYANDA07234420fae2ab-fcce-b026-be00-d9aa2f396f7d

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551541124AcephenANDACardinal Health2011-06-06ACETAMINOPHENRECTALSUPPOSITORY007130164ANDA0723441922c613-a8e2-4cf2-ab8b-bbc65c394309
2617860152AcephenANDARemedyrepack Inc.2015-03-09ACETAMINOPHENRECTALSUPPOSITORY007130164ANDA0723448136458a-1f35-4ab0-be50-b89bcd10624f

acetaminophen 650 mg rectal suppository

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516722117FeverallNDATaro Pharmaceuticals U.S.A., Inc.2013-12-12ACETAMINOPHENRECTALSUPPOSITORYNDA0183377afa4b78-5e14-4723-a87b-01f664b0c0e9

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007130165AcephenANDAG&W Laboratories, Inc.1992-03-27ACETAMINOPHENRECTALSUPPOSITORYANDA072237ab9a9048-75b7-904c-6683-06d7de69ec52
2458020730ANDAPerrigo New York Inc2010-10-28ACETAMINOPHENRECTALSUPPOSITORYANDA070608b43974c3-4db9-4201-beee-b22596a2b241

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684991ANDAPhysicians Total Care, Inc.2004-02-03ACETAMINOPHENRECTALSUPPOSITORY458020730ANDA070608cddc841a-ab37-4480-a9d1-4764cba3ec80
2551546050FeverallNDACardinal Health2011-06-06ACETAMINOPHENRECTALSUPPOSITORY004721203NDA018337f90b4520-8e08-4bbb-ada4-f494cefcd311
3551548850AcephenANDACardinal Health2011-06-06ACETAMINOPHENRECTALSUPPOSITORY007130165ANDA072237d0469b34-486f-451f-9319-48771df6857a

acetaminophen 80 mg rectal suppository

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516722114FeverallNDATaro Pharmaceuticals U.S.A., Inc.2013-12-12ACETAMINOPHENRECTALSUPPOSITORYNDA0183373ade895b-5dca-4d81-9415-8091923162ff

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070607ACETAMINOPHENPERRIGO NEW YORK INC1987-04-06ANDA070607_001
2ANDA070608ACETAMINOPHENPERRIGO NEW YORK INC1986-12-01ANDA070608_001
3ANDA071010ACETAMINOPHENTrueROXANE LABORATORIES INC1987-05-12ANDA071010_001
4ANDA071011ACETAMINOPHENTrueROXANE LABORATORIES INC1987-05-12ANDA071011_001
5ANDA072218ACEPHENTrueG AND W LABORATORIES INC1992-03-27ANDA072218_001
6ANDA072237ACEPHENG AND W LABORATORIES INC1992-03-27ANDA072237_001
7ANDA072344ACEPHENG AND W LABORATORIES INC1992-03-27ANDA072344_001
8ANDA073106ACETAMINOPHENTrueABLE LABORATORIES INC1995-02-27ANDA073106_001
9ANDA073107ACETAMINOPHENTrueABLE LABORATORIES INC1995-02-27ANDA073107_001
10ANDA073108ACETAMINOPHENTrueABLE LABORATORIES INC1995-02-27ANDA073108_001
11NDA016401NEOPAPPOLYMEDICA INDUSTRIES INCNDA016401_001
12NDA017756TYLENOLTrueJOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIVISIONNDA017756_001, NDA017756_002
13NDA018060ACEPHENG AND W LABORATORIES INCNDA018060_001, NDA018060_002, NDA018060_003
14NDA018337ACETAMINOPHENTARO PHARMACEUTICALS NORTH AMERICA INCNDA018337_001, NDA018337_002, NDA018337_003, NDA018337_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA070607_001OTCACETAMINOPHEN (120MG)RECTALSUPPOSITORYFalse1987-04-06ACETAMINOPHEN
2ANDA070608_001OTCACETAMINOPHEN (650MG)RECTALSUPPOSITORYFalse1986-12-01ACETAMINOPHEN
3ANDA071010_001discontinuedACETAMINOPHEN (120MG)RECTALSUPPOSITORYFalse1987-05-12ACETAMINOPHEN
4ANDA071011_001discontinuedACETAMINOPHEN (650MG)RECTALSUPPOSITORYFalse1987-05-12ACETAMINOPHEN
5ANDA072218_001discontinuedACETAMINOPHEN (120MG)RECTALSUPPOSITORYFalse1992-03-27ACEPHEN
6ANDA072237_001OTCACETAMINOPHEN (650MG)RECTALSUPPOSITORYFalse1992-03-27ACEPHEN
7ANDA072344_001OTCACETAMINOPHEN (325MG)RECTALSUPPOSITORYFalse1992-03-27ACEPHEN
8ANDA073106_001discontinuedACETAMINOPHEN (120MG)RECTALSUPPOSITORYFalse1995-02-27ACETAMINOPHEN
9ANDA073107_001discontinuedACETAMINOPHEN (325MG)RECTALSUPPOSITORYFalse1995-02-27ACETAMINOPHEN
10ANDA073108_001discontinuedACETAMINOPHEN (650MG)RECTALSUPPOSITORYFalse1995-02-27ACETAMINOPHEN
11NDA016401_001OTCACETAMINOPHEN (120MG)RECTALSUPPOSITORYFalseNEOPAP
12NDA017756_001discontinuedACETAMINOPHEN (650MG)RECTALSUPPOSITORYFalseTYLENOL
13NDA017756_002discontinuedACETAMINOPHEN (120MG)RECTALSUPPOSITORYFalseTYLENOL
14NDA018060_001OTCACETAMINOPHEN (120MG)RECTALSUPPOSITORYFalseACEPHEN
15NDA018060_002OTCACETAMINOPHEN (650MG)RECTALSUPPOSITORYFalseACEPHEN
16NDA018060_003OTCACETAMINOPHEN (325MG)RECTALSUPPOSITORYFalse1986-12-18ACEPHEN
17NDA018337_001OTCACETAMINOPHEN (650MG)RECTALSUPPOSITORYTrueACETAMINOPHEN
18NDA018337_002OTCACETAMINOPHEN (325MG)RECTALSUPPOSITORYFalseACETAMINOPHEN
19NDA018337_003OTCACETAMINOPHEN (120MG)RECTALSUPPOSITORYFalse1983-09-12ACETAMINOPHEN
20NDA018337_004OTCACETAMINOPHEN (80MG)RECTALSUPPOSITORYFalse1992-08-26ACETAMINOPHEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11922c613-a8e2-4cf2-ab8b-bbc65c394309 (view SPL)Drug FactsotcHuman OTCCardinal HealthREPACK2015-03-093551541124
220fae2ab-fcce-b026-be00-d9aa2f396f7d (view SPL)AcephenTM Acetaminophen SuppositoriesUSP325 mgotcHuman OTCG&W Laboratories, Inc.MANUFACTURE2012-01-122007130164
32f1d555e-ad12-4b3c-9b2f-d824fed38400 (view SPL)FeverAll (Acetaminophen Suppositories) INFANTSotcHuman OTCActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-08-228004721200
432bbe845-7f0e-c33d-adb2-659f18fedfa9 (view SPL)Pediatric AcephenTM Acetaminophen Suppositories USP, 120 mgotcHuman OTCG&W Laboratories, Inc.MANUFACTURE2012-01-125007130118
53561bbc3-53b0-4857-8b71-39e165ed95ce (view SPL)Feverall Jr. StrengthotcHuman OTCTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-09-252516722116
63ade895b-5dca-4d81-9415-8091923162ff (view SPL)Feverall Infants'otcHuman OTCTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-09-252516722114
741292088-026f-4cfe-a52b-956660d9f12e (view SPL)FeverAll (Acetaminophen Suppositories) ADULTSotcHuman OTCActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-08-227004721203
86282b264-191b-4cf3-b579-a26dbfb4ff01 (view SPL)FeverAll (Acetaminophen Suppositories) JUNIOR STRENGTHotcHuman OTCActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-08-216004721202
962b3d354-d7f5-4ba0-b233-ea6be0d7ff03 (view SPL)Perrigo Acetaminophen Suppositories USP, 120 mg Drug FactsotcHuman OTCPerrigo New York Inc2015-01-073458020732
106444d200-e32c-4848-80c3-6a23a213fbad (view SPL)Perrigo Acetaminophen Suppositories USP, 120 mg Drug FactsotcHuman OTCPreferred Pharmaceuticals, Inc.RELABEL2014-09-246687880426
1172a33640-ca7f-460d-9357-772d5bf56bac (view SPL)Topco Associates LLC. Fever Reducer Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2015-03-092368000579
127afa4b78-5e14-4723-a87b-01f664b0c0e9 (view SPL)Feverall AdultsotcHuman OTCTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-09-252516722117
138136458a-1f35-4ab0-be50-b89bcd10624f (view SPL)AcephenTM Acetaminophen SuppositoriesUSP325 mgprescriptionHuman PrescriptionRemedyrepack Inc.2015-03-091617860152
14861e2987-5473-45b0-b2a6-f980a9b0e809 (view SPL)Feverall Children'sotcHuman OTCTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-09-252516722115
159d89544f-3a66-4f23-b609-381d027e0c95 (view SPL)CVS Pharmacy, Inc. Fever Reducing Suppositories Drug FactsotcHuman OTCCvs2015-10-283597790579
16a9864f73-abb2-4cb1-a692-a48efdeeedf8 (view SPL)Perrigo Acetaminophen Suppositories USP, 120 mg Drug FactsotcHuman OTCA-S Medication Solutions Llcrelabel2015-02-151500900001
17ab9a9048-75b7-904c-6683-06d7de69ec52 (view SPL)AcephenTM Acetaminophen Suppositories USP650 mgotcHuman OTCG&W Laboratories, Inc.MANUFACTURE2012-01-122007130165
18b43974c3-4db9-4201-beee-b22596a2b241 (view SPL)Perrigo Acetaminophen Suppositories USP, 650 mg Drug FactsotcHuman OTCPerrigo New York Inc2015-01-073458020730
19c3075d2a-2a4f-45b2-8894-fc04c45643ad (view SPL)FeverAll (Acetaminophen Suppositories) CHILDRENotcHuman OTCActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-08-228004721201
20c383bf5b-7043-4f0c-bddb-590aea545859 (view SPL)Pediatric AcephenTM, Acetaminophen Suppositories, 120 mgotcHuman OTCPhysicians Total Care, Inc.relabel2012-06-061548685624
21cddc841a-ab37-4480-a9d1-4764cba3ec80 (view SPL)otcHuman OTCPhysicians Total Care, Inc.relabel2011-04-131548684991
22d0469b34-486f-451f-9319-48771df6857a (view SPL)Drug FactsotcHuman OTCCardinal HealthREPACK2015-03-117551548850
23daaad04e-4fe8-40ce-9022-1115e9f3a42a (view SPL)Walgreen Co. Fever Reducer for Children Drug FactsotcHuman OTCWalgreens2015-01-072003630706
24f2085b26-5778-4656-8de3-9edd83f914dd (view SPL)Walgreen Co. Pain Reliever/Fever Reducer Drug FactsotcHuman OTCWalgreens2011-09-141003630579
25f90b4520-8e08-4bbb-ada4-f494cefcd311 (view SPL)Feverall 650 mgotcHuman OTCCardinal HealthREPACK2012-11-163551546050

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII