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 26 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	WALMART INC.	321430a5-11c9-4d33-8638-5149f601f1bb	2026-05-22	Warnings	Exact identifier application number: M012
dg health cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp Inc	ddcc1e78-4ea8-4489-88e7-86ff46016464	2026-05-21	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTH	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e	2026-05-21	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	525467fb-510d-0b4b-e063-6294a90acd36	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4cee80e5-e412-e832-e063-6394a90aeb90	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Reckitt Benckiser LLC	4a9464cf-0c77-23d0-e063-6394a90a62f1	2026-05-21	Warnings	Exact identifier application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	Reckitt Benckiser LLC	4ceda68e-c7ce-eb87-e063-6394a90a8ded	2026-05-21	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	5258ea3f-87f1-7f86-e063-6394a90ab82f	2026-05-21	Warnings	Exact identifier application number: M012
RELIABLE-1 ANTI DRIP PUMP MIST	OXYMETAZOLINE HYDROCHLORIDE	Reliable 1 Laboratories LLC	7df9905d-09aa-4c84-8b6f-6e5ed90df0da	2026-05-21	Warnings	Exact identifier application number: M012
daytime nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Publix Super Markets Inc	80abb6b8-b0d5-4f19-8588-50b8717510bb	2026-05-21	Warnings	Exact identifier application number: M012
FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEF	OXYMETAZOLINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES INC	27163169-54d0-4b6e-94cd-721b29b18249	2026-05-20	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Cough Fast	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	5241b11a-72c8-5e67-e063-6394a90a4353	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	50b140ad-aba2-ce6b-e063-6294a90ae2f8	2026-05-20	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Recharge Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	4bae240c-70ce-e9c2-e063-6394a90a5f3d	2026-05-20	Warnings	Exact identifier application number: M012
Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	85f7d60b-32ec-4ec2-86ec-f677093bce1d	2026-05-20	Warnings	Exact identifier application number: M012
Chloraseptic Nighttime Sore Throat Hot Relief	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	9c13c052-a5d1-43d2-8d29-4ea011a971ac	2026-05-20	Warnings	Exact identifier application number: M012
Cold and Flu Severe, Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	a0bff310-2d35-4a18-815b-8386e44730a2	2026-05-19	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	61a1beb3-decf-4c8d-a402-93a02ec40a43	2026-05-19	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold plus Flu Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	52291746-2bbf-8f3f-e063-6294a90adcfc	2026-05-19	Warnings	Exact identifier application number: M012
MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCI	Reckitt Benckiser LLC	fdb70793-5dd1-0455-e053-6394a90ac621	2026-05-19	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