Allergy Relief

Product NDC: 54859-811
11-digit product format: 548590811
Labeler code: 54859
Product ID: 54859-811_4745ebec-acaf-77c4-e063-6394a90aee07
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-01
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/5mL
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	12.5 mg/5mL

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
1049906	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
e086a6d2-f664-454e-9524-f656bfbf45df	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
54859-811-16	Allergy Relief	473 mL in 1 BOTTLE	LIQUID	473		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-811-16	ML - Milliliter	54859-811	153468a1-1be5-43fc-a3fd-ea1aae92bbb3	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-811	ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	3	Current NDC, Legacy NDC, 1 package rows	20241222_e086a6d2-f664-454e-9524-f656bfbf45df.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 125 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	aebc7cf8-aaf7-4746-89f5-a64d0be1641e	2024-12-26	Warnings	Exact identifier application number: M012
Foster and Thrive Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a1661a66-5e8c-4144-9c82-cbbcc75fb222	2024-12-23	Warnings	Exact identifier application number: M012
Geri Dryl	DIPHENHYDRAMINE HCL	GERI-CARE PHARMACEUTICALS, CORP	34d36146-6827-4800-8483-c0edb8f4cc28	2024-12-23	Warnings	Exact identifier application number: M012
Guaiasorb DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	6299e352-116e-43f2-b40f-c704a7bd5d61	2024-12-23	Warnings	Exact identifier application number: M012
Equaline Chest Congestion Relief	GUAIFENESIN	United Natural Foods, Inc. dba UNFI	ad9fde8b-10cd-4778-917d-1ed6b67e5ab1	2024-12-23	Warnings	Exact identifier application number: M012
Equaline Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	United Natural Foods, Inc. dba UNFI	a40f5893-eb96-4e0e-b965-d78293c48dc9	2024-12-23	Warnings	Exact identifier application number: M012
Tukol X-Pecto Miel Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	b9d32964-5bd7-44b0-be98-827d5310ed4f	2024-12-20	Warnings	Exact identifier application number: M012
Halls Honey Vanilla	MENTHOL	Mondelez Global LLC	8e94a1b8-8915-4595-b097-8a0a319d54aa	2024-12-20	Warnings	Exact identifier application number: M012
Halls Sugar Free Mentho-Lyptus	MENTHOL	Mondelez Global LLC	96046858-c57b-426e-8279-91b35e05bcdb	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Best Choice	LEVMETAMFETAMINE	Valu Merchandisers Company	3f1c086c-bc22-4abb-9921-565a13f30c20	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler	LEVMETAMFETAMINE NASAL DECONGESTANT	Walgreens	77924474-ccc7-497b-9168-91490bcfadfc	2024-12-20	Warnings	Exact identifier application number: M012
Levmetamfetamine	LEVMETAMFETAMINE	Meijer, Inc.	d11e916f-90a6-4099-bf83-75f2dfbd6266	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, DG health	LEVMETAMFETAMINE	Dolgencorp Inc.	5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd3	2024-12-20	Warnings	Exact identifier application number: M012
Tukol Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	aef2ad43-145d-4abc-bccc-2c5fdd6882f9	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare health	LEVMETAMFETAMINE	Topco Associates LLC	8f995561-759a-4837-a82a-640417a6f889	2024-12-20	Warnings	Exact identifier application number: M012
Childrens Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores, Inc.	50a0eaa5-fa73-4d84-86fc-3546c85cf353	2024-12-20	Warnings	Exact identifier application number: M012
Equate Childrens Multi symptom Cold Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler	LEVMETAMFETAMINE NASAL DECONGESTANT	C.D.M.A., Inc.	904b7e21-cce5-4b96-afc1-b36f532f98ac	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Equaline	LEVMETAMFETAMINE	Supervalu Inc.	44f72f34-d0b8-421f-b240-86286de874cf	2024-12-20	Warnings	Exact identifier application number: M012
Childrens Tussnex	ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Guardian Drug Company	19e9678d-ac34-4af8-a80f-d08fce0a5f0e	2024-12-19	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
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	e086a6d2-f664-454e-9524-f656bfbf45df	4
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	e086a6d2-f664-454e-9524-f656bfbf45df	4
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	e086a6d2-f664-454e-9524-f656bfbf45df	4
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	e086a6d2-f664-454e-9524-f656bfbf45df	4
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	e086a6d2-f664-454e-9524-f656bfbf45df	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-811-16	54859081116	473 mL in 1 BOTTLE (54859-811-16)	473 ml	2019-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens - Allergy Relief 811	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2025-12-31	HUMAN OTC DRUG LABEL	4