Allergy Relief

Product NDC: 61504-090
11-digit product format: 615040090
Labeler code: 61504
Product ID: 61504-090_092d4666-dc81-1c0f-e063-6294a90a7aaf
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: AMERIFOODS TRADING COMPANY
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-30
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
f6cece6c-23e4-7811-e053-6394a90a106a	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
61504-090-03	Allergy Relief	100 in 1 BOTTLE, PLASTIC	TABLET, COATED	100		2
61504-090-03	Allergy Relief	1 in 1 CARTON	TABLET, COATED	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61504-090	ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AMERIFOODS TRADING COMPANY]	2	Current NDC, 2 package rows	20231103_f6cece6c-23e4-7811-e053-6394a90a106a.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 148 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough and Cold XL3 Xtra	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	da5b31dd-becd-471a-9392-d0ee4b8f9539	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3 FORTE	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	MIDWAY IMPORTING INC.	58252f15-485c-3061-e053-2a91aa0a2320	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Midway Importing, Inc.	e41b9beb-e274-5c02-e053-2995a90ad0f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	38e70a28-eff2-4a48-b829-8cd68e80beef	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Xpect	GUAIFENSIN, DEXTROMETHORPHAN	Midway Importing Inc.	c2c8bd26-bbf1-c2e6-e053-2995a90a86a7	2024-10-17	Warnings	Exact identifier application number: M012
Antiflu Des Cough and Flu	ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE	Productos Farmaceuticos, S.A. de C.V.	dcf3897a-a793-6df7-e053-2995a90a25f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FSA STORE INC.	ec6aef90-ece1-4fe6-e053-2995a90a9310	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Cold, Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	c8eebe64-00bf-436d-a9fc-1623401bebfa	2024-10-16	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	4f42c8d2-0538-4bcd-aac0-e26103a30499	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	9ac3e24a-d18a-48fc-8005-55393085d57b	2024-10-16	Warnings	Exact identifier application number: M012
Nighttime Cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	45471fdd-c4cd-46ad-a932-aa37327e8a41	2024-10-16	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	8cb15a8d-c836-4167-bc6b-dd20a34076e8	2024-10-16	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f4497e56-c69d-4ae9-bd81-80bf2ee1b17f	2024-10-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	8256c1fb-683d-56ab-e053-2a91aa0ac197	2024-10-15	Warnings	Exact identifier application number: M012
SINUS SEVRE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f9586e3-a8b4-4060-e053-2995a90aa068	2024-10-15	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f95715f-63dc-6086-e053-2a95a90adb0c	2024-10-15	Warnings	Exact identifier application number: M012
Allergy MultiSymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	a61636e9-8fe2-8419-e053-2a95a90a011c	2024-10-15	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f95b2e8-dea4-ef59-e053-2a95a90a0bcb	2024-10-15	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	d2dcbc7c-e66c-4922-83df-c706a37bf334	2024-10-15	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC. (	9f958d97-8dcf-332d-e053-2995a90a0a65	2024-10-15	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	f6cece6c-23e4-7811-e053-6394a90a106a	2
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	f6cece6c-23e4-7811-e053-6394a90a106a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
61504-090-03	61504009003	1 BOTTLE, PLASTIC in 1 CARTON (61504-090-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2023-10-30	No	No	Current