Allergy Relief

Product NDC: 41163-329
11-digit product format: 411630329
Labeler code: 41163
Product ID: 41163-329_8a45588f-d0b1-4f3c-8418-2324c8c90abd
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: United Natural Foods, Inc. dba UNFI
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1990-03-02
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: 2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41163-329	41163-329-12	D	Discontinued by firm		2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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 Relief
Listing expiration: 2026-12-31

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
4517c7ef-156c-42b8-a2da-165e936f0837	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41163-329-08	Allergy Relief	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	18
41163-329-08	Allergy Relief	2 in 1 CARTON	TABLET, FILM COATED	2	18
41163-329-12	Allergy Relief	100 in 1 BOTTLE	TABLET, FILM COATED	100	18
41163-329-12	Allergy Relief	1 in 1 CARTON	TABLET, FILM COATED	1	18
41163-329-22	Allergy Relief	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	18
41163-329-22	Allergy Relief	4 in 1 CARTON	TABLET, FILM COATED	4	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41163-329-08	EA - Each	41163-329	b55a5746-95a7-4b09-b675-0735a3c8a23c	1	2023-05-05
41163-329-12	EA - Each	41163-329	ecd24238-f405-4f3e-ac66-184f573fb7bd	1	2016-06-14
41163-329-22	EA - Each	41163-329	de5d2551-c8ae-4274-aff6-af86e35d083f	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-329	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]	17	Current NDC, Legacy NDC, 6 package rows	20241023_4517c7ef-156c-42b8-a2da-165e936f0837.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 27 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Fast-Max Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	3270f369-7a40-186d-e063-6394a90a8526	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	fe44d1ee-1e03-b74f-e053-6294a90a8bb4	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	31ac6883-ffcd-39de-e063-6294a90a52dd	2026-05-19	Warnings	Exact identifier application number: M012
MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	325b41e1-f8d2-02ee-e063-6394a90aafff	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	326f1fd3-73ab-e515-e063-6294a90ab222	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	6c85df30-a601-4de6-9fd6-818265d799ff	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	7050b583-c09b-4457-9a9c-70c0923b62c0	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	27312ee4-d1f4-4a95-9c45-91fa5a01f5ba	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Daytime Pain, Headache, and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	37de53a7-5546-3804-e063-6294a90a0fb5	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	36b07e49-c72c-45e5-e063-6394a90a804a	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus Max Clear and Cool Severe Congestion	OXYMETAZOLINE HCI	Reckitt Benckiser LLC	2ee95e17-bd94-d717-e063-6294a90a2173	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus Max Sinus Pressure Severe Congestion	OXYMETAZOLINE HCI	Reckitt Benckiser LLC	2eeafd83-230c-af92-e063-6294a90a984e	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Congestion and Headache Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d7017328-f8af-4601-9232-dc1104feaa0a	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain Headache and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	32375b12-75ed-d605-e063-6294a90ad004	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	07da45b5-d05e-41b1-b233-f7034d556a8d	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	ad4e0e4d-cc1f-4176-835f-3ba76564c634	2026-05-19	Warnings	Exact identifier application number: M012
Childrens Mucinex Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	60daf6e2-ded8-44e6-bd8d-9d221384adde	2026-05-19	Warnings	Exact identifier application number: M012
Mucinex Childrens Mini Melts Cold and Flu	ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	401fe0a0-ec97-5248-e063-6394a90af27f	2026-05-19	Warnings	Exact identifier application number: M012
Childrens Cough and Congestion, Childrens Cold and Cough Day, Night	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	WALMART INC.	312ae879-1124-40a4-b2ba-3f3070840021	2026-05-19	Warnings	Exact identifier application number: M012
GOOD SENSE DAYTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	L. Perrigo Company	2597e84c-18b4-41a9-8e6a-ff0c4c1f0612	2026-05-18	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	4517c7ef-156c-42b8-a2da-165e936f0837	18
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	4517c7ef-156c-42b8-a2da-165e936f0837	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-329-08	41163032908	2 BLISTER PACK in 1 CARTON (41163-329-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	1990-03-02	0000-00-00	No	No	Current
41163-329-12	41163032912	100 in 1 BOTTLE						Historical
41163-329-22	41163032922	4 BLISTER PACK in 1 CARTON (41163-329-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	1990-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equaline 44-329	United Natural Foods, Inc. dba UNFI \| LNK International, Inc.	2025-10-27	HUMAN OTC DRUG LABEL	18