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 38 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vicks Sinex Severe Original	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	cfd048c9-2f33-101d-e053-2995a90ad854	2026-04-22	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	d0768332-7c24-7c30-e053-2a95a90a26d4	2026-04-22	Warnings	Exact identifier application number: M012
Histanaz	PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE	Capital Pharmaceutical, LLC	3e87d0f3-f16c-5972-e063-6294a90acc8a	2026-04-22	Warnings	Exact identifier application number: M012
Good Sense Severe Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	L. Perrigo Company	d5faf89f-3641-4be1-8d43-35504f12fe8d	2026-04-22	Warnings	Exact identifier application number: M012
Multi-Symptom Cold childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALMART INC.	5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd4	2026-04-22	Warnings	Exact identifier application number: M012
good sense nasal	OXYMETAZOLINE HYDROCHLORIDE	L. Perrigo Company	95f23049-e523-4c59-904c-b8e9ae82602c	2026-04-22	Warnings	Exact identifier application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	c07dad99-87b0-419b-9230-7c22a77ecf9e	2026-04-21	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Valu Merchandisers Company	83db90da-9155-4f6a-8209-44c87d14b696	2026-04-21	Warnings	Exact identifier application number: M012
Pain, Headache and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	613a2516-fc61-4bb4-bd44-ca6004548193	2026-04-21	Warnings	Exact identifier application number: M012
Dr. Simi Allergy Relief	DIPHENHYDRAMINE HCL	Farmacias De Similares TX LLC	4fe8bbe3-13c9-5458-e063-6294a90a9064	2026-04-20	Warnings	Exact identifier application number: M012
Cold and Flu Day and Night, Severe	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	58d722ef-db67-44ac-a295-dd10e1f5ca1d	2026-04-20	Warnings	Exact identifier application number: M012
Loratadine 10mg	LORATADINE	BETTER LIVING BRANDS, LLC	46d615dd-45d5-2dfc-e063-6394a90a5d42	2026-04-18	Warnings	Exact identifier application number: M012
Multi-Symptom Cold Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Valu Merchandisers Company	d0f896a6-5637-45ef-bf60-b343cbcdcf7e	2026-04-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Bryant Ranch Prepack	9ed5611f-4e1d-4f71-b430-a2a949bf7fe5	2026-04-17	Warnings	Exact identifier application number: M012
Multi-Symptom Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Valu Merchandisers Company	bf3158af-89ab-4b7c-9f39-0f316fbe9056	2026-04-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Bryant Ranch Prepack	761825bc-f835-4947-bfa0-2940f1dff5fb	2026-04-17	Warnings	Exact identifier application number: M012
equate cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	e83d14cc-9b90-40ce-a00a-2702d8a8968f	2026-04-17	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	0b34b5a3-98a2-4096-9d95-071bb5a63c86	2026-04-17	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN	Walgreen Company	1cd69ede-29c6-4216-95b7-b58fc96c084b	2026-04-16	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Valu Merchandisers Company	cdcb8e0d-7847-4f28-bb09-7dc7b5d35c13	2026-04-16	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