FDA.reportPublic FDA data

topcare sleep aid

Product NDC
36800-431
11-digit product format
368000431
Labeler code
36800
Product ID
36800-431_b0cba6ea-b6ae-42a0-aaae-055d03fb8254
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2001-09-11
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
topcare sleep aid
Brand name suffix
nighttime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30284271-0411-4abf-bc62-d956dc794432Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-431-622024-01-30C16284748780-11030e365-6e3b-111a-e063-dadaa90a10e2Topco Associates LLC. Nighttime Sleep Aid Drug Facts
36800-431-672024-01-30C16284748780-11030e365-6e3b-111a-e063-dadaa90a10e2Topco Associates LLC. Nighttime Sleep Aid Drug Facts
36800-431-782024-01-30C16284748780-11030e365-6e3b-111a-e063-dadaa90a10e2Topco Associates LLC. Nighttime Sleep Aid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-431-62topcare sleep aidnighttime12 in 1 CARTONTABLET, FILM COATED128
36800-431-62topcare sleep aidnighttime2 in 1 BLISTER PACKTABLET, FILM COATED28
36800-431-67topcare sleep aidnighttime24 in 1 CARTONTABLET, FILM COATED248
36800-431-67topcare sleep aidnighttime2 in 1 BLISTER PACKTABLET, FILM COATED28
36800-431-78topcare sleep aidnighttime100 in 1 BOTTLETABLET, FILM COATED1008
36800-431-78topcare sleep aidnighttime1 in 1 CARTONTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-431-62EA - Each36800-431449e653e-75b4-4421-9fa6-f9eda8dbd3ad12012-07-24
36800-431-67EA - Each36800-431b240e965-3ece-4b7f-b6e7-8c7315ba1e6612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40TOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-431TOPCARE SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 6 package rows20240724_30284271-0411-4abf-bc62-d956dc794432.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 14 · 262 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
application number: M010
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationedfe32b5-9213-4350-9508-2530ee26c5d52026-09-02WarningsExact identifier
application number: M010
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
application number: M010
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsExact identifier
application number: M010
Wal Som Nighttime Sleep Aid NighttimeDIPHENHYDRAMINE HCLWalgreens4cb0f9ab-1be1-4b41-a233-bbd0327036e22026-08-28WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEKroger514aa6b5-c33b-494c-e063-6294a90a7ace2026-08-27WarningsExact identifier
application number: M010
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEHyVee Inc496ce4ba-08a9-ee99-e063-6294a90ac9a72026-08-21WarningsExact identifier
application number: M010
CVS Nighttime Childrens Cold and Cough Multi-Symptom ReliefCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDECVS PHARMACYd66b1a2e-49b6-473b-acec-2694c73ce8b42026-08-19WarningsExact identifier
application number: M010
CVS Childrens Nighttime Multi Symptom ColdACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d2026-08-19WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.a575a914-14a0-442c-a504-ac7a0aa0ac772026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.e8785ba8-e53e-491e-bbfe-04e860f361312026-08-18WarningsExact identifier
application number: M010
CVS Health Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy,Inc.9f944edc-a317-4967-ae54-67b5d183591b2026-08-18WarningsExact identifier
application number: M010
SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp4b6fc81e-e3ba-4a36-834c-82766311aa732026-08-17WarningsExact identifier
application number: M010
CVS Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENCVS PHARMACY333e170e-52cd-4218-8d15-0bf3c5c75cb92026-08-14WarningsExact identifier
application number: M010
CVS NightTime ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY0f0cc40d-7939-4d4d-a931-b4de4070fea12026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEShield Pharmaceuticals Corp8db277e2-9d98-40b6-8000-a51c57fb4ece2026-08-14WarningsExact identifier
application number: M010
Theraflu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY4b567234-1da9-4e10-a427-877eea2be1c12026-08-14WarningsExact identifier
application number: M010
CVS Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS PHARMACY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed32026-08-14WarningsExact identifier
application number: M010
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLC6fb6cfde-30a6-419c-973d-8abdc72611ed2026-08-07WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN30284271-0411-4abf-bc62-d956dc7944328
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD30284271-0411-4abf-bc62-d956dc7944328

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-431-623680004316212 BLISTER PACK in 1 CARTON (36800-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2001-09-110000-00-00NoNoCurrent
36800-431-673680004316724 BLISTER PACK in 1 CARTON (36800-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2004-01-270000-00-00NoNoCurrent
36800-431-78368000431781 BOTTLE in 1 CARTON (36800-431-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-09-130000-00-00NoNoCurrent