FDA.reportPublic FDA data

DG Health Allergy

Product NDC
55910-479
Requested package NDC
55910-479-78
11-digit product format
559100479
Labeler code
55910
Product ID
55910-479_fa20a1d9-5d4f-4690-9b6c-48956c17527b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dolgencorp, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-01-30
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55910-47955910-479-78DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

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
55910-479-782024-01-30C16284748780-11030e365-2623-111a-e063-dadaa90a10e2Dolgencorp, LLC Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-479-78DG Health Allergy1 in 1 CARTONTABLET17
55910-479-78DG Health Allergy100 in 1 BOTTLETABLET1007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPDG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-479DG HEALTH ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [DOLGENCORP INC]7Legacy NDC, 2 package rows20240719_1a70b768-d202-487f-abbf-d74a9b70f261.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN1a70b768-d202-487f-abbf-d74a9b70f2617
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD1a70b768-d202-487f-abbf-d74a9b70f2617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-479-78559100479781 BOTTLE in 1 CARTON (55910-479-78) > 100 TABLET in 1 BOTTLE1 bottle2010-01-300000-00-00NoNoCurrent