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	2026-10-15
excluded package	package	41250-479	41250-479-62	D	Discontinued by firm	2026-10-15
excluded package	package	41250-479	41250-479-67	D	Discontinued by firm	2026-10-15

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 23 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theraflu Severe Congestion Relief Cooling Nasal Mist	OXYMETAZOLINE HCL	Haleon US Holdings LLC	90125a19-eed7-4ca4-a6dc-f38026c74d54	2026-06-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	54254b61-7861-4eeb-bd3c-54fd5266f4a7	2026-06-08	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Major Pharmaceuticals	aa662428-e61f-4e22-af4d-8cf63df68c99	2026-06-08	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, GUAIFENESIN AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	TARGET CORPORATION	47a218a0-6395-36bd-e063-6394a90a265a	2026-06-05	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL	TARGET CORPORATION	4779288a-9850-8490-e063-6394a90abe51	2026-06-05	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCL	Reckitt Benckiser LLC	4df37cfb-299f-661f-e063-6394a90ab337	2026-06-04	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	53715ea4-42b3-5887-e063-6294a90a4249	2026-06-04	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Chain Drug Marketing Association, Inc.	b0d38db9-22a9-4dd8-8e0f-dd81805e724b	2026-06-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS PHARMACY	65d4d7ea-c080-404e-9836-7d6bdcc5ea7d	2026-06-04	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fe9d6a6e-38a1-44ae-a30f-596c5ec7d057	2026-06-03	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	b0c1d635-0f85-433a-b479-51c68d259faa	2026-06-03	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Walgreen Company	de4e8af4-d3d0-44b3-aea3-79016803ccdc	2026-06-03	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR AND GUAIFENESIN	ARMY AND AIR FORCE EXCHANGE SERVICE	dc0a3761-bbe2-4261-a183-594f5fb12b0b	2026-06-03	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALMART INC.	f278cc81-65b2-4e45-be5b-41152cbb67c4	2026-06-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	358ba91d-06a4-49c9-994d-4e4bf9499dcd	2026-06-03	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	Cardinal Health 107, LLC	c5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed	2026-06-02	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5349dbde-730c-610f-e063-6394a90a952a	2026-06-02	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	Cardinal Health 107, LLC	a9130f36-4761-4e6b-a383-eca3db06ea93	2026-06-02	Warnings	Exact identifier application number: M012
Topcare Day Time Nite Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	aed387e0-5a8b-4caf-a373-3e04496a4983	2026-06-02	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu And Congestion Severe Fast Hot Liquid Day	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	53371691-2510-5039-e063-6394a90a6ea9	2026-06-01	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