allergy

Product NDC
41250-479
11-digit product format
412500479
Labeler code
41250
Product ID
41250-479_4ec300ab-2512-4a5f-ba03-ea3ea2666056
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Meijer Distribution Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-09-06
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
2027-12-31
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-47941250-479-53DDiscontinued by firm2026-10-23
excluded packagepackage41250-47941250-479-62DDiscontinued by firm2026-10-23
excluded packagepackage41250-47941250-479-67DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 34 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0541250-479-62d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541250-479-67d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0541250-479-53d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2641250-479-62f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641250-479-67f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2641250-479-53f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3141250-479-622ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141250-479-672ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3141250-479-532ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2841250-479-62a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841250-479-67a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2841250-479-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2141250-479-62cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141250-479-67cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2141250-479-53cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1041250-479-62cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041250-479-67cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1041250-479-53cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3141250-479-62302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141250-479-67302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3141250-479-53302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2041250-479-62ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041250-479-67ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2041250-479-53ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1041250-479-620efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041250-479-670efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1041250-479-530efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0841250-479-62ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841250-479-67ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0841250-479-53ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0341250-479-62367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341250-479-67367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0341250-479-53367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0941250-479-53557ba5c1ecfa…9c80585c8c6e…

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
allergy
Listing expiration
2027-12-31

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
f1e83e43-011c-4470-bd55-fb2818a9fc84Available 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-479-53allergy1 in 1 BLISTER PACKTABLET16
41250-479-53allergy12 in 1 CARTONTABLET126
41250-479-62allergy24 in 1 CARTONTABLET246
41250-479-62allergy1 in 1 BLISTER PACKTABLET16
41250-479-67allergy48 in 1 CARTONTABLET486
41250-479-67allergy1 in 1 BLISTER PACKTABLET16
41250-479-78allergy1 in 1 CARTONTABLET16
41250-479-78allergy100 in 1 BOTTLETABLET1006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-479ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]6Current NDC, Legacy NDC, 8 package rows20240713_f1e83e43-011c-4470-bd55-fb2818a9fc84.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 131 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINEBest Choice (Valu Merchandisers Company)539b8972-2a46-468e-ad27-6672d746feb72024-12-10WarningsExact identifier
application number: M012
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.db2ab9be-507d-4768-9d00-188f751b77262024-12-10WarningsExact identifier
application number: M012
Adult Allergy ReliefCALMCO ALLERGY RELIEFCalmCo08288825-0f38-b6a3-e063-6394a90aa3582024-12-07WarningsExact identifier
application number: M012
Original Herb Cough DropsMENTHOLRicola Agc142663f-086e-4ab7-a758-9107d70775372024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag984c9793-163c-4b97-b244-9b471966a1222024-12-05WarningsExact identifier
application number: M012
BENZEDREXPROPYLHEXEDRINEBF ASCHER AND CO INC00d8c237-3eee-1d9f-e063-6394a90aeb862024-12-05WarningsExact identifier
application number: M012
Cold Multi Symptom Daytime NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Associationd5cbb5b0-564c-429e-b680-fa683e7963932024-12-05WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCarede8a623f-7b10-4d56-a74b-3737e7716ffe2024-12-05WarningsExact identifier
application number: M012
Cold Max DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC9773958b-c5e5-4da7-a8e9-6b6c223a2b302024-12-05WarningsExact identifier
application number: M012
Cold Plus Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC399e0e51-c2a7-451c-b74d-d3db140cef692024-12-05WarningsExact identifier
application number: M012
Head Congestion Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI09531edc-8dbd-451f-ae02-f922e9e8c2482024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag71ca8af7-172d-40da-be1e-ff3ab5568e742024-12-05WarningsExact identifier
application number: M012
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola Agb790a91c-33be-4bc3-bdeb-eae6f366f0852024-12-05WarningsExact identifier
application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANTMENTHOLRicola Agea42e516-2ef8-41c9-ae4e-571f0147bc6b2024-12-05WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE SWISS CHERRYMENTHOLRicola Ag8b2d5c0f-509e-447d-b071-d73c4785f1202024-12-05WarningsExact identifier
application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola Ag8ae0e21a-44a0-4a2c-9880-54eeeaea07ea2024-12-05WarningsExact identifier
application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag6d82469b-d51c-4824-9830-6c1874ad4fe42024-12-05WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINTMENTHOLRicola Age8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce52024-12-05WarningsExact identifier
application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Aga535717d-ba55-45e9-9fc3-711b5d7dbf572024-12-05WarningsExact identifier
application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPSMENTHOLRicola Ag4330ee8d-0b37-4a93-886b-5fc6e6598da72024-12-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNf1e83e43-011c-4470-bd55-fb2818a9fc846
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDf1e83e43-011c-4470-bd55-fb2818a9fc846

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-479-534125004795312 BLISTER PACK in 1 CARTON (41250-479-53) > 1 TABLET in 1 BLISTER PACK12 blister pack2018-07-060000-00-00NoNoCurrent
41250-479-624125004796224 BLISTER PACK in 1 CARTON (41250-479-62) > 1 TABLET in 1 BLISTER PACK24 blister pack1991-09-060000-00-00NoNoCurrent
41250-479-674125004796748 BLISTER PACK in 1 CARTON (41250-479-67) > 1 TABLET in 1 BLISTER PACK48 blister pack1998-03-120000-00-00NoNoCurrent
41250-479-78412500479781 BOTTLE in 1 CARTON (41250-479-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1993-05-270000-00-00NoNoCurrent