Allergy Relief

Product NDC: 67091-425
11-digit product format: 670910425
Labeler code: 67091
Product ID: 67091-425_e55e7a67-ccc5-48ae-a8aa-0f2b232a4c2d
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: WinCo Foods, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-03-28
Marketing end: 2027-07-31
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 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
1049900	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
2cbf27b6-217c-46d8-89c9-e46f3668f002	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67091-425-20	Allergy Relief	4 in 1 CARTON	TABLET, CHEWABLE	4		3
67091-425-20	Allergy Relief	5 in 1 BLISTER PACK	TABLET, CHEWABLE	5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67091-425	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WINCO FOODS, LLC]	2	Current NDC, 2 package rows	20240828_2cbf27b6-217c-46d8-89c9-e46f3668f002.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 176 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Lil' Drug Store Products, Inc.	e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b	2023-10-02	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	PD-Rx Pharmaceuticals, Inc.	ac8c0c15-b305-47f2-8712-e4b53636f7fa	2023-10-02	Warnings	Exact identifier application number: M012
Maximum strength Day cold and flu and Night severe cold and flu	ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS	TIME CAP LABORATORIES,INC	fff69901-965c-5372-e053-6394a90a29c2	2023-09-18	Warnings	Exact identifier application number: M012
Tussin Mucus and Chest Congestion Sugar Free	GUAIFENESIN	AARNA USA, Inc.	6e488782-0138-436d-a9f0-0ec5bc9daedd	2023-05-15	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	KROGER COMPANY	813b1db2-a177-77c6-e053-2a91aa0ac73b	2023-01-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	DEXTROMETHORPHAN HBR/GUAIFENESIN	KROGER COMPANY	813baf42-edb0-33a9-e053-2a91aa0a8599	2023-01-17	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H-E-B	db19b8c7-0334-0664-e053-2a95a90ad61f	2023-01-14	Warnings	Exact identifier application number: M012
Nightime	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	H-E-B	db44560b-da02-74c9-e053-2a95a90af0b6	2023-01-13	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	dbf5656b-9105-871b-e053-2995a90a4941	2023-01-03	Warnings	Exact identifier application number: M012
DAYTIME-NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	KROGER	a2508699-08c0-4a22-e053-2a95a90a8a6d	2022-11-02	Warnings	Exact identifier application number: M012
GUAIFENESIN	GUAIFENESIN	PAI Holdings, LLC dba PAI Pharma	c2e53fb5-2798-47c8-9285-d1077d46e629	2022-06-14	Warnings	Exact identifier application number: M012
Mucus Relief DM	MUCUS RELIEF DM	TopCo Associates, LLC	71674a9b-89ed-43d1-aadb-b9311fdfbdf9	2022-06-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Combo Pack	DAYTIME NIGHTTIME COLD AND FLU	Allegiant Health	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	2022-05-19	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Good Sense	26a199bf-57e5-4f36-b40c-83a1187e4870	2022-05-18	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Allegiant Health	731f8608-ad5b-491e-a4d4-2bb0c423fed5	2022-05-18	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b3c229a4-c772-70fb-e053-2a95a90a72db	2022-03-11	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Good Sense	f88e2654-8e97-4cf6-9c36-01aeb51a9102	2021-11-30	Warnings	Exact identifier application number: M012
Cold Medicine	COLD MEDICINE	Allegiant Health	443fbc44-2c33-4316-ad31-dcc5a5aa8f52	2021-11-23	Warnings	Exact identifier application number: M012
Decongestant PE Non Drowsy	PHENYLEPHRINE HCL	Allegiant Health	7a3098b4-381c-4f32-97a7-87b53fd64428	2021-06-16	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN 400MG	Good Sense	e7c68746-7ec0-46cf-b4a3-174fab819b5e	2021-05-05	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
1049900	diphenhydrAMINE HCl 12.5 MG Chewable Tablet	PSN	2cbf27b6-217c-46d8-89c9-e46f3668f002	3
1049900	diphenhydramine hydrochloride 12.5 MG Chewable Tablet	SCD	2cbf27b6-217c-46d8-89c9-e46f3668f002	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67091-425-20	67091042520	4 BLISTER PACK in 1 CARTON (67091-425-20) / 5 TABLET, CHEWABLE in 1 BLISTER PACK	4 blister pack	2024-03-28	2027-07-31	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WinCo 44-585 Delisted	WinCo Foods, LLC \| LNK International, Inc.	2026-07-17	HUMAN OTC DRUG LABEL	4