FDA.reportPublic FDA data

dg health sleep aid

Product NDC
55910-431
11-digit product format
559100431
Labeler code
55910
Product ID
55910-431_f76ae49d-ed13-4e63-8906-9f5ff89201b2
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp Inc
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-24
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
dg health sleep aid
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
038c1b4e-43f5-4370-896b-97da1b0a89caAvailable 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
55910-431-622024-01-30C16284748780-11030e365-68cc-111a-e063-dadaa90a10e2Dolgencorp, LLC Sleep Aid Drug Facts
55910-431-672024-01-30C16284748780-11030e365-68cc-111a-e063-dadaa90a10e2Dolgencorp, LLC Sleep Aid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-431-62dg health sleep aid12 in 1 CARTONTABLET, FILM COATED128
55910-431-62dg health sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED28
55910-431-67dg health sleep aid2 in 1 BLISTER PACKTABLET, FILM COATED28
55910-431-67dg health sleep aid24 in 1 CARTONTABLET, FILM COATED248

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPDG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-431DG HEALTH SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP INC]8Current NDC, Legacy NDC, 4 package rows20240724_038c1b4e-43f5-4370-896b-97da1b0a89ca.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 13 · 259 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 TabletPSN038c1b4e-43f5-4370-896b-97da1b0a89ca8
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD038c1b4e-43f5-4370-896b-97da1b0a89ca8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-431-625591004316212 BLISTER PACK in 1 CARTON (55910-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2010-01-240000-00-00NoNoCurrent
55910-431-675591004316724 BLISTER PACK in 1 CARTON (55910-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2012-09-180000-00-00NoNoCurrent