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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	41250-479	41250-479-53	D	Discontinued by firm	2026-10-23
excluded package	package	41250-479	41250-479-62	D	Discontinued by firm	2026-10-23
excluded package	package	41250-479	41250-479-67	D	Discontinued by firm	2026-10-23

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 date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	41250-479-62	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41250-479-67	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41250-479-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	41250-479-62	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41250-479-67	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41250-479-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	41250-479-62	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41250-479-67	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41250-479-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	41250-479-62	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41250-479-67	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41250-479-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	41250-479-62	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41250-479-67	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41250-479-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	41250-479-62	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41250-479-67	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41250-479-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	41250-479-62	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41250-479-67	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41250-479-53	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	41250-479-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41250-479-67	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41250-479-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	41250-479-62	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41250-479-67	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41250-479-53	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	41250-479-62	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41250-479-67	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41250-479-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	41250-479-62	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41250-479-67	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41250-479-53	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	41250-479-53	`557ba5c1ecfa…`	`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
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f1e83e43-011c-4470-bd55-fb2818a9fc84	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
41250-479-53	Meijer Distribution, Inc. Allergy Tablets Drug Facts
41250-479-53	Meijer Distribution, Inc. Allergy Tablets Drug Facts
41250-479-62	Meijer Distribution, Inc. Allergy Tablets Drug Facts
41250-479-62	Meijer Distribution, Inc. Allergy Tablets Drug Facts
41250-479-67	Meijer Distribution, Inc. Allergy Tablets Drug Facts
41250-479-67	Meijer Distribution, Inc. Allergy Tablets Drug Facts
41250-479-78	Meijer Distribution, Inc. Allergy Tablets Drug Facts
41250-479-78	Meijer Distribution, Inc. Allergy Tablets Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41250-479-53	allergy	1 in 1 BLISTER PACK	TABLET	1	6
41250-479-53	allergy	12 in 1 CARTON	TABLET	12	6
41250-479-62	allergy	24 in 1 CARTON	TABLET	24	6
41250-479-62	allergy	1 in 1 BLISTER PACK	TABLET	1	6
41250-479-67	allergy	48 in 1 CARTON	TABLET	48	6
41250-479-67	allergy	1 in 1 BLISTER PACK	TABLET	1	6
41250-479-78	allergy	1 in 1 CARTON	TABLET	1	6
41250-479-78	allergy	100 in 1 BOTTLE	TABLET	100	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-479	ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MEIJER DISTRIBUTION INC]	6	Current NDC, Legacy NDC, 8 package rows	20240713_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 167 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Robitussin Cough Long-Acting	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	75bc7827-4439-e6a8-a65c-7154d5592e58	2024-03-17	Warnings	Exact identifier application number: M012
Childrens Robitussin Nighttime Cough Long-Acting DM	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c	2024-03-17	Warnings	Exact identifier application number: M012
ANTIGRIP Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Pharmadel LLC	12f20aba-f991-bd82-e063-6294a90a4aac	2024-03-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	WALGREENS	d3053f80-aece-eb50-e053-2a95a90a5945	2024-03-15	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCL	WALGREENS	d315bc95-1b46-75df-e053-2a95a90a6c66	2024-03-15	Warnings	Exact identifier application number: M012
MAR-COF CG Expectorant	CODEINE PHOSPHATE AND GUAIFENESIN	Marnel Pharmaceuticals, LLC	60a41229-b125-43d8-b2b4-0bf40feed764	2024-03-15	Warnings	Exact identifier application number: M012
Night Time Cough	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	97aa0b90-1230-4143-b5d3-18b96a6b7b4f	2024-03-15	Warnings	Exact identifier application number: M012
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	036162c9-f5a6-418e-bd5e-ebd72097d27d	2024-03-15	Warnings	Exact identifier application number: M012
Bronkaid Max	EPHEDRINE SULFATE	Foundation Consumer Healthcare LLC	9a0b792a-caee-41f6-9400-922a5ebd592f	2024-03-14	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	A-S Medication Solutions	5f2b16f0-c58b-4e48-ad92-eaab93c6c4b2	2024-03-12	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE	A-S Medication Solutions	ffcae882-0b19-4219-bbee-a175c63d79c8	2024-03-11	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime with Honey Ginger Flavor	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	18dcede2-5a38-40fa-93fe-48acdd6a7cf1	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime with Honey Elderberry Flavor	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	d4ce06aa-776f-45e4-a1a6-9cf13797048f	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	14e38ef0-a5e7-4df7-824f-f27bef664d25	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Maximum Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	68d3e88a-d1be-410b-92a1-863903b3aa61	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	0d3b1bea-e2ca-4e07-8ae5-60627d230c96	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu PowerPods Daytime Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	e655c33c-c319-41d9-ae55-cf747242cd10	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Berry Burst	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	adf33520-4689-4de2-b9d8-c201518e9d26	2024-03-08	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f6ae9e3a-6bea-40e0-8a6f-45f4be8319e7	2024-03-07	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	2024-03-07	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	f1e83e43-011c-4470-bd55-fb2818a9fc84	6
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	f1e83e43-011c-4470-bd55-fb2818a9fc84	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-479-53	41250047953	12 BLISTER PACK in 1 CARTON (41250-479-53) > 1 TABLET in 1 BLISTER PACK	12 blister pack	2018-07-06	0000-00-00	No	No	Current
41250-479-62	41250047962	24 BLISTER PACK in 1 CARTON (41250-479-62) > 1 TABLET in 1 BLISTER PACK	24 blister pack	1991-09-06	0000-00-00	No	No	Current
41250-479-67	41250047967	48 BLISTER PACK in 1 CARTON (41250-479-67) > 1 TABLET in 1 BLISTER PACK	48 blister pack	1998-03-12	0000-00-00	No	No	Current
41250-479-78	41250047978	1 BOTTLE in 1 CARTON (41250-479-78) / 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	1993-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Allergy Tablets Drug Facts	Meijer Distribution Inc	2026-07-30	HUMAN OTC DRUG LABEL	7