Allergy Relief

Product NDC: 69452-445
11-digit product format: 694520445
Labeler code: 69452
Product ID: 69452-445_54dcfbdc-23e6-c4e3-e063-6294a90ad945
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET
Route: ORAL
Labeler: BIONPHARMA INC.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-08-11
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 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
1085945	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
3c1953a1-32e9-6c81-e063-6294a90a9fa2	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
69452-445-24	Allergy Relief	1 in 1 CARTON	TABLET	1	3
69452-445-24	Allergy Relief	150 in 1 BOTTLE	TABLET	150	3
69452-445-77	Allergy Relief	12 in 1 BLISTER PACK	TABLET	12	3
69452-445-77	Allergy Relief	4 in 1 CARTON	TABLET	4	3

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 175 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	eb64750f-19ac-655f-e053-2995a90a33b5	2023-11-02	Warnings	Exact identifier application number: M012
Multi-Symptom Mapap Cold Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Proficient Rx LP	9bf81b26-38b4-486c-ae89-222119ce1a4f	2023-11-01	Warnings	Exact identifier application number: M012
Guaifenesin Syrup and Dextromethorphan	GUAIFENESIN SYRUP AND DEXTROMETHORPHAN	Natco Pharma USA LLC	ad9026f4-f0b6-4d02-aa44-f0460eeefc0e	2023-11-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HYDROCHLORIDE	Natco Pharma USA LLC	54b64354-ac10-42ff-a53d-96cef933a91a	2023-11-01	Warnings	Exact identifier application number: M012
children allergy relief dye free cherry	DIPHENHYDRAMINE HCL	A-S Medication Solutions	5c6c1809-4c6f-4e8f-a5ae-9796e821d400	2023-11-01	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0903b222-1a44-64aa-e063-6294a90abba0	2023-10-31	Warnings	Exact identifier application number: M012
Ephrine Nose Drops	PHENYLEPHRINE HYDROCHLORIDE	Walgreens	b620eb9f-2caf-0942-e053-2a95a90ae48e	2023-10-31	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	204849d1-ac4b-4dbe-8769-fcb30291f880	2023-10-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	DAYTIME COLD AND FLU RELIEF	TopCo Associates, LLC	d592fbb8-d4bf-444e-982e-edf6fe97dce4	2023-10-31	Warnings	Exact identifier application number: M012
Nite Time Cold and Flu Relief	NITE TIME COLD AND FLU RELIEF	TopCo Associates, LLC	407dc4ae-882d-4a49-8884-ef048bb404cf	2023-10-31	Warnings	Exact identifier application number: M012
12 Hour Original Nasal Decongestant	NASAL SPRAY	Sheffield Pharmaceuticals LLC	cea0ce76-ae75-4484-a7c2-ff1086e9d8b0	2023-10-30	Warnings	Exact identifier application number: M012
Mucosa DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Magno-Humphries, Inc.	3a5533fb-1c83-4b95-9cd2-9be663d3ff5f	2023-10-27	Warnings	Exact identifier application number: M012
Mucosa Guifenesin	GUAIFENESIN	Magno-Humphries, Inc.	9d22c208-d0ae-8b6a-e053-2995a90ab90a	2023-10-27	Warnings	Exact identifier application number: M012
DG Health Cough Drops Cherry Flavor	MENTHOL	Dollar General Corporation	c7a603d8-72fb-9626-e053-2995a90a09ea	2023-10-26	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Geri-Care Pharmaceutical Corp	92d90b41-0627-121e-e053-2995a90a2df1	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Cherry	MENTHOL	Riclan S.A.	8e471265-3594-451a-8921-f0db474abe85	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Eucalyptus	MENTHOL	Riclan S.A.	1141593a-f3ba-4adf-b332-f9fcb0b5a013	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Honey Lemon	MENTHOL	Riclan S.A.	f6271e85-9ca2-41d3-9bff-a13670ac5b80	2023-10-26	Warnings	Exact identifier application number: M012
Freegells Cough Drops Menthol Strawberry	MENTHOL	Riclan S.A.	da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457	2023-10-26	Warnings	Exact identifier application number: M012
DG Health Cough Drops Assorted Flavors	MENTHOL	Dollar General Corporation	c731d255-40f2-3cb3-e053-2a95a90a8877	2023-10-26	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
1085945	diphenhydrAMINE HCl 50 MG Oral Tablet	PSN	3c1953a1-32e9-6c81-e063-6294a90a9fa2	3
1085945	diphenhydramine hydrochloride 50 MG Oral Tablet	SCD	3c1953a1-32e9-6c81-e063-6294a90a9fa2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69452-445-24	69452044524	1 BOTTLE in 1 CARTON (69452-445-24) / 150 TABLET in 1 BOTTLE	1 bottle	2025-08-11	No	No	Current
69452-445-77	69452044577	4 BLISTER PACK in 1 CARTON (69452-445-77) / 12 TABLET in 1 BLISTER PACK	4 blister pack	2025-08-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine HCl 50 mg tablet, A+ Health, allergy relief dye free	BIONPHARMA INC. \| OrBion Pharmaceuticals Private Limited \| JOHNSON & SMITH COMPANY	2026-06-22	HUMAN OTC DRUG LABEL	4