Doxylamine Oral Tablet

Brand(s)
Unisom
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Chattem, Inc. (2014-07-31)
Oldest Current Product
1978-10-18
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\DOXYLAMINE
FDAOB
ORAL\TABLET\DOXYLAMINE SUCCINATE
SPL Active
ORAL\TABLET\DOXYLAMINE SUCCINATE
SPL Moiety
ORAL\TABLET\DOXYLAMINE

product(s) by strength(s)

doxylamine succinate 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1411670060UnisomNDAChattem, Inc.1978-10-18DOXYLAMINE SUCCINATEORALTABLETNDA018066d5e3015c-49ae-4288-a78f-17a141f26817

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130441ANDAL. Perrigo Company1997-04-14DOXYLAMINE SUCCINATEORALTABLETANDA040167f0a0eb93-96e0-432b-9b82-f0e891483be0
2003630441ANDAWalgreens1999-03-05DOXYLAMINE SUCCINATEORALTABLETANDA040167b80da99b-d98d-4ff2-a353-192399b84a01
3102020441ANDA7-Eleven2014-08-05DOXYLAMINE SUCCINATEORALTABLETANDA040167f01921ff-ed85-4f09-88bf-9abaf26e1c1c
4118220386ANDARite Aid2001-04-11DOXYLAMINE SUCCINATEORALTABLETANDA04056499883c0a-4152-440e-b626-4af6ed07a2ff
5211300386ANDABetter Living Brands Llc2002-04-11DOXYLAMINE SUCCINATEORALTABLETANDA040564c7dea3ea-c9f5-4903-859b-3b7a3762f07e
6243850441ANDAGood Neighbor Pharmacy1997-06-26DOXYLAMINE SUCCINATEORALTABLETANDA0401678051a431-94ab-4593-bfca-f28ea988b474
7301420158ANDAKroger2014-07-15DOXYLAMINE SUCCINATEORALTABLETANDA040167c5f276c2-f56c-43eb-b9bb-21f323d7f449
8301420441ANDAKroger1997-05-02DOXYLAMINE SUCCINATEORALTABLETANDA04016781396b39-0d20-4fa4-8ace-0f127031cf9e
9368000441ANDATop Care (Topco Associates Llc)1997-01-29DOXYLAMINE SUCCINATEORALTABLETANDA04016715dc89c4-b7ce-4d36-8107-f501daaf289b
10372050121ANDACardinal Health1997-10-21DOXYLAMINE SUCCINATEORALTABLETANDA0401673a259420-6b3c-418a-be1e-9cbac1d247e6
11372050671ANDACardinal Health2002-04-11DOXYLAMINE SUCCINATEORALTABLETANDA0405644b8adfd2-caf6-4376-ae7e-b82e9c405fb2
12378080386ANDAH-E-B2002-04-11DOXYLAMINE SUCCINATEORALTABLETANDA04056416f88417-d6cc-47fd-af6c-e916626c1bc3
13378080441ANDAH-E-B1998-05-06DOXYLAMINE SUCCINATEORALTABLETANDA0401678be7575a-7ff3-4ca9-b5f2-d16b0b0c3a0c
14411630386ANDASupervalu, Inc2002-04-11DOXYLAMINE SUCCINATEORALTABLETANDA040564cb213889-10f0-402e-b093-a86491fc2a5b
15411630441ANDASupervalu, Inc2004-08-10DOXYLAMINE SUCCINATEORALTABLETANDA0401676379013a-b473-4c77-ad82-cf438b411b21
16412500441ANDAMeijer Distribution, Inc1997-02-21DOXYLAMINE SUCCINATEORALTABLETANDA040167de0a6f68-6988-44df-9fab-b87620fd32e8
17412680441ANDAHannaford Brothers Company1997-02-07DOXYLAMINE SUCCINATEORALTABLETANDA0401679149ea04-8433-4eb1-8ee8-b67fae4714ba
18415200441ANDAFoodhold U.S.A., Llc2004-06-29DOXYLAMINE SUCCINATEORALTABLETANDA0401677cdc9334-6c73-4696-baa4-fca91f22cc06
19425070033ANDAHy-Vee2014-12-04DOXYLAMINE SUCCINATEORALTABLETANDA04016795b12a14-21ee-431d-a892-46f8cdca2d7a
20425070441ANDAHy-Vee1998-09-01DOXYLAMINE SUCCINATEORALTABLETANDA04016786c7d568-bcd9-43fa-adc8-4cfdfb57558a
21490350863ANDAWalmart2002-04-11DOXYLAMINE SUCCINATEORALTABLETANDA0405645b0bf558-31e9-4b95-b946-84d160a73572
22493480574ANDASunmark2003-08-15DOXYLAMINE SUCCINATEORALTABLETANDA0401677792bf14-ac56-48e5-996d-b66404608152
23497380441ANDAKmart Corp2010-12-29DOXYLAMINE SUCCINATEORALTABLETANDA040167bb99c54f-c9af-4082-b0d2-792886ee38d9
24553120441ANDAWestern Family1997-11-11DOXYLAMINE SUCCINATEORALTABLETANDA04016745c8c3ba-250e-45c7-b89b-63af80346131
25553150386ANDAFreds Inc2002-04-11DOXYLAMINE SUCCINATEORALTABLETANDA0405643be11f23-5143-418d-bd18-e84565c8cf7e
26553160441ANDADza Brands,2011-06-06DOXYLAMINE SUCCINATEORALTABLETANDA040167622fbd93-7603-4812-950c-27c810a7d81d
27597790441ANDACvs1997-07-23DOXYLAMINE SUCCINATEORALTABLETANDA04016705050b61-2417-48f0-9478-c39d6a341026
28597790863ANDACvs2002-04-11DOXYLAMINE SUCCINATEORALTABLETANDA040564acacdecc-cc25-405d-a0bb-6f0a891c4d02
29620110037ANDAMckesson (Health Mart)2011-11-21DOXYLAMINE SUCCINATEORALTABLETANDA040167b8816996-3132-402e-adae-b150c1f84b74
30639810386ANDACostco Wholesale Company2002-04-11DOXYLAMINE SUCCINATEORALTABLETANDA04056401bc2491-4deb-4f4c-990e-9bc7783120ae
31639810441ANDACostco Wholesale Company2003-06-27DOXYLAMINE SUCCINATEORALTABLETANDA0401679673fc65-72d4-47a5-abeb-0b9c293ef00b
32640920350ANDAGreat Lakes Wholesale, Marketing, & Sales, Inc.2002-04-11DOXYLAMINE SUCCINATEORALTABLETANDA040564a1914355-2669-4010-a42a-e9ee54804f47

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040167DOXYLAMINE SUCCINATEL PERRIGO CO1996-09-18ANDA040167_001
2ANDA040564DOXYLAMINE SUCCINATELNK INTERNATIONAL INC2004-08-27ANDA040564_001
3ANDA070156DOXY-SLEEP-AIDTruePAR PHARMACEUTICAL INC1987-07-02ANDA070156_001
4ANDA088603DOXYLAMINE SUCCINATETrueQUANTUM PHARMICS LTD1984-08-07ANDA088603_001
5ANDA088900DOXYLAMINE SUCCINATETrueCOPLEY PHARMACEUTICAL INC1988-02-12ANDA088900_002
6NDA006412DECAPRYNTrueSANOFI AVENTIS US LLCNDA006412_014, NDA006412_015
7NDA018066UNISOMCHATTEM INCNDA018066_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040167_001OTCDOXYLAMINE SUCCINATE (25MG)ORALTABLETFalse1996-09-18DOXYLAMINE SUCCINATE
2ANDA040564_001OTCDOXYLAMINE SUCCINATE (25MG)ORALTABLETFalse2004-08-27DOXYLAMINE SUCCINATE
3ANDA070156_001discontinuedDOXYLAMINE SUCCINATE (25MG)ORALTABLETFalse1987-07-02DOXY-SLEEP-AID
4ANDA088603_001discontinuedDOXYLAMINE SUCCINATE (25MG)ORALTABLETFalse1984-08-07DOXYLAMINE SUCCINATE
5ANDA088900_002discontinuedDOXYLAMINE SUCCINATE (25MG)ORALTABLETFalse1988-02-12DOXYLAMINE SUCCINATE
6NDA006412_014discontinuedDOXYLAMINE SUCCINATE (25MG)ORALTABLETFalseDECAPRYN
7NDA006412_015discontinuedDOXYLAMINE SUCCINATE (12.5MG)ORALTABLETFalseDECAPRYN
8NDA018066_001OTCDOXYLAMINE SUCCINATE (25MG)ORALTABLETTrueUNISOM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101bc2491-4deb-4f4c-990e-9bc7783120ae (view SPL)Kirkland 44-386otcHuman OTCCostco Wholesale CompanyMANUFACTURE, PACK2015-06-115639810386
205050b61-2417-48f0-9478-c39d6a341026 (view SPL)CVS Pharmacy, Inc. Nighttime Sleep Aid Tablets Drug FactsotcHuman OTCCvs2009-06-031597790441
315dc89c4-b7ce-4d36-8107-f501daaf289b (view SPL)Topco Associates LLC. Sleep Aid Tablets Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2014-07-172368000441
416f88417-d6cc-47fd-af6c-e916626c1bc3 (view SPL)HEB 44-386otcHuman OTCH-E-BMANUFACTURE, PACK2013-09-051378080386
53a259420-6b3c-418a-be1e-9cbac1d247e6 (view SPL)Cardinal Health Sleep Aid Tablets Drug FactsotcHuman OTCCardinal Health2009-06-031372050121
63be11f23-5143-418d-bd18-e84565c8cf7e (view SPL)Freds 44-386otcHuman OTCFreds IncMANUFACTURE, PACK2012-11-191553150386
745c8c3ba-250e-45c7-b89b-63af80346131 (view SPL)Western Family Sleep Aid Tablets Drug FactsotcHuman OTCWestern Family2014-07-172553120441
84b8adfd2-caf6-4376-ae7e-b82e9c405fb2 (view SPL)Leader 44-386otcHuman OTCCardinal HealthMANUFACTURE2015-06-194372050671
95b0bf558-31e9-4b95-b946-84d160a73572 (view SPL)Equate 44-386otcHuman OTCWalmartMANUFACTURE, PACK2015-09-094490350863
10622fbd93-7603-4812-950c-27c810a7d81d (view SPL)DZA Brands, LLC Sleep Aid Tablets Drug FactsotcHuman OTCDza Brands,2014-07-172553160441
116379013a-b473-4c77-ad82-cf438b411b21 (view SPL)SuperValu Sleep Aid Tablets Drug FactsotcHuman OTCSupervalu, Inc2009-06-031411630441
127792bf14-ac56-48e5-996d-b66404608152 (view SPL)McKesson Sleep Aid Tablets Drug FactsotcHuman OTCSunmark2014-07-172493480574
137cdc9334-6c73-4696-baa4-fca91f22cc06 (view SPL)American Sales Company Sleep Aid Drug FactsotcHuman OTCFoodhold U.S.A., Llc2014-07-172415200441
148051a431-94ab-4593-bfca-f28ea988b474 (view SPL)Amerisource Bergen Sleep Aid Tablets Drug FactsotcHuman OTCGood Neighbor Pharmacy2014-07-173243850441
1581396b39-0d20-4fa4-8ace-0f127031cf9e (view SPL)Kroger Co. Sleep Aid Tablets Drug FactsotcHuman OTCKroger2010-03-292301420441
1686c7d568-bcd9-43fa-adc8-4cfdfb57558a (view SPL)Hy-Vee Sleep Aid Tablets Drug FactsotcHuman OTCHy-Vee2009-06-031425070441
178be7575a-7ff3-4ca9-b5f2-d16b0b0c3a0c (view SPL)HEB Sleep Aid Tablets Drug FactsotcHuman OTCH-E-B2011-12-152378080441
189149ea04-8433-4eb1-8ee8-b67fae4714ba (view SPL)Hannaford Bros. Co. Sleep Aid Tablets Drug FactsotcHuman OTCHannaford Brothers Company2009-06-031412680441
1995b12a14-21ee-431d-a892-46f8cdca2d7a (view SPL)Hy-Vee, Inc. Nighttime Sleep Aid Drug FactsotcHuman OTCHy-Vee2015-01-232425070033
209673fc65-72d4-47a5-abeb-0b9c293ef00b (view SPL)Costco Wholesale Corp. Sleep Aid Drug FactsotcHuman OTCCostco Wholesale Company2012-07-132639810441
2199883c0a-4152-440e-b626-4af6ed07a2ff (view SPL)Rite Aid 44-386otcHuman OTCRite AidMANUFACTURE, PACK2015-11-043118220386
22a1914355-2669-4010-a42a-e9ee54804f47 (view SPL)Healthcare 44-386otcHuman OTCGreat Lakes Wholesale, Marketing, & Sales, Inc.MANUFACTURE, PACK2015-09-142640920350
23acacdecc-cc25-405d-a0bb-6f0a891c4d02 (view SPL)CVS 44-386otcHuman OTCCvsMANUFACTURE, PACK2015-11-064597790863
24b80da99b-d98d-4ff2-a353-192399b84a01 (view SPL)Walgreen Co. Wal-Som Drug FactsotcHuman OTCWalgreens2014-11-143003630441
25b8816996-3132-402e-adae-b150c1f84b74 (view SPL)McKesson Sleep Aid Tablets Drug FactsotcHuman OTCMckesson (Health Mart)2014-07-172620110037
26bb99c54f-c9af-4082-b0d2-792886ee38d9 (view SPL)Kmart Corporation Sleep Aid Drug FactsotcHuman OTCKmart Corp2014-07-172497380441
27c5f276c2-f56c-43eb-b9bb-21f323d7f449 (view SPL)Kroger Co. Nighttime Sleep-Aid Drug FactsotcHuman OTCKroger2014-07-151301420158
28c7dea3ea-c9f5-4903-859b-3b7a3762f07e (view SPL)Signature Care 44-386otcHuman OTCBetter Living Brands LlcMANUFACTURE, PACK2015-10-284211300386
29cb213889-10f0-402e-b093-a86491fc2a5b (view SPL)Equaline 44-386otcHuman OTCSupervalu, IncMANUFACTURE, PACK2015-08-262411630386
30d5e3015c-49ae-4288-a78f-17a141f26817 (view SPL)Unisom SleepTabsotcHuman OTCChattem, Inc.2014-07-317411670060
31de0a6f68-6988-44df-9fab-b87620fd32e8 (view SPL)Meijer Distribution, Inc. Sleep Aid Drug FactsotcHuman OTCMeijer Distribution, Inc2014-07-173412500441
32f01921ff-ed85-4f09-88bf-9abaf26e1c1c (view SPL)7-Eleven Sleep Aid Tablets Drug FactsotcHuman OTC7-Eleven2015-03-062102020441
33f0a0eb93-96e0-432b-9b82-f0e891483be0 (view SPL)Perrigo Sleep Aid Tablets Drug FactsotcHuman OTCL. Perrigo Company2014-07-172001130441

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