Allergy Relief

Product NDC: 81522-109
11-digit product format: 815220109
Labeler code: 81522
Product ID: 81522-109_24999d88-1a63-7029-e063-6394a90ad4a9
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: FSA STORE INC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-01-11
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

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
ec6aef90-ece1-4fe6-e053-2995a90a9310	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	Strength	SPL version
81522-109-03	Allergy Relief	1 in 1 CARTON	TABLET, COATED	1		3
81522-109-03	Allergy Relief	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81522-109	ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FSA STORE INC.]	3	Current NDC, Legacy NDC, 2 package rows	20241018_ec6aef90-ece1-4fe6-e053-2995a90a9310.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 128 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Family Dollar Services Inc	8aee8108-a4e0-4956-8e37-6b3b1c5dc683	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Chest Congestion Relief	GUAIFENESIN	TOPCO ASSOCIATES LLC	b8339617-17ce-4ad7-af38-399ecc74d864	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	THE KROGER CO	976bfdcf-2110-486c-aa6e-cd2067334cdc	2024-12-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Mucus Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	AmerisourceBergen Drug Corp	79cefd46-bd19-4a1d-9cb1-e85ff0f12494	2024-12-18	Warnings	Exact identifier application number: M012
Leader Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Cardinal Health	8397e1b9-e83e-4c6a-b858-1663c2365840	2024-12-18	Warnings	Exact identifier application number: M012
GNP Mucus Relief PE	GUAIFENESIN/PHENYLEPHRINE	AmerisourceBergen Drug Corp	63932e68-b09d-4500-bc1d-cfb2c267df1c	2024-12-18	Warnings	Exact identifier application number: M012
Meijer Chest Congestion Relief	GUAIFENESIN	Meijer Distribution Inc.	ae02e0bd-d9e7-495f-b01f-b135b96934a0	2024-12-18	Warnings	Exact identifier application number: M012
Topcare Chest Congestion and Sinus Congestion Relief PE	GUAIFENESIN/PHENYLEPHRINE	TOPCO ASSOCIATES LLC	b6c0362f-86ca-4f08-ba53-800c6df2c025	2024-12-18	Warnings	Exact identifier application number: M012
Sunmark Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Strategic Sourcing Services LLC	10cad9a7-1223-470c-9027-807891217d40	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Mucus Relief	GUAIFENESIN	THE KROGER CO	2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e	2024-12-18	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	41f88b43-3e0a-4650-b167-a72afe6177e8	2024-12-18	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Rugby Laboratories	5da36516-9f94-49cb-9421-0c310abcd116	2024-12-18	Warnings	Exact identifier application number: M012
Kroger Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	THE KROGER CO	430c6604-93a7-4df6-a657-ba438aa61425	2024-12-18	Warnings	Exact identifier application number: M012
Discount Drugmart Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart, Inc	1ac281e1-22ea-42f8-98fe-ab3d5ff9a208	2024-12-18	Warnings	Exact identifier application number: M012
TopCare Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	4c50233e-1dcb-427d-ba63-1538cf370061	2024-12-18	Warnings	Exact identifier application number: M012
Dollar General Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Dolgencorp, LLC	718f08d2-3757-4f3e-915e-3e4982ad090f	2024-12-18	Warnings	Exact identifier application number: M012
Good Neighbor Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	AmerisourceBergen Drug Corp	e4610d53-4459-43a0-9351-f0ac8586df60	2024-12-18	Warnings	Exact identifier application number: M012
Always Save Mucus Relief PE	GUAIFENESIN/PHENYLEPHRINE	Valu Merch	5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f6	2024-12-17	Warnings	Exact identifier application number: M012
Chestrub	CAMPHOR MENTHOL EUCALYPTUS OIL	Delta Brands Inc	8e6f731f-c16a-41b2-9786-0cab588cfc8e	2024-12-17	Warnings	Exact identifier application number: M012
Mentholatum Nighttime Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	5539ae74-9723-480d-b35f-0a6644bf54ad	2024-12-17	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	ec6aef90-ece1-4fe6-e053-2995a90a9310	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	ec6aef90-ece1-4fe6-e053-2995a90a9310	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
81522-109-03	81522010903	1 BOTTLE, PLASTIC in 1 CARTON (81522-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2023-01-11	0000-00-00	No	No	Current