Diphenhydramine HCl Oral Solution

Product NDC: 84415-012
11-digit product format: 844150012
Labeler code: 84415
Product ID: 84415-012_2bd97cb8-2b08-aa8d-e063-6394a90ad19d
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl Oral
Dosage form: SOLUTION
Route: ORAL
Labeler: Everpharm LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-16
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: Diphenhydramine HCl Oral Solution
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
d7aaf874-69ac-49cf-93be-6d4a38b9a557	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
84415-012-01	Diphenhydramine HCl Oral Solution	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5		1
84415-012-01	Diphenhydramine HCl Oral Solution	100 in 1 BOX, UNIT-DOSE	SOLUTION	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
84415-012-01	ML - Milliliter	84415-012	70a458ce-939c-46d2-af0e-ca6a0fd1cc2d	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84415-012	DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [EVERPHARM LLC]	1	Current NDC, 2 package rows	20250119_d7aaf874-69ac-49cf-93be-6d4a38b9a557.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 154 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oxymetazoline hcl	OXYMETAZOLINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	a1103cd8-344b-4a65-8a60-3c7be86d01a6	2024-09-11	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	L. Perrigo Company	276d7d3c-c4a7-4754-8845-c38f85aac5f7	2024-09-08	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	4ff5a4ae-9649-4a6d-a5f8-ca23efbbb479	2024-09-08	Warnings	Exact identifier application number: M012
equate nasal original	OXYMETAZOLINE HYDROCHLORIDE	Wal-Mart Stores Inc	7e40c9b8-e0b5-448a-a674-72388fbab189	2024-09-08	Warnings	Exact identifier application number: M012
Anefrin Nasal Original	OXYMETAZOLINE HYDROCHLORIDE	Walgreen Company	85b442dc-1703-4fef-948a-fad7cbe9f224	2024-09-07	Warnings	Exact identifier application number: M012
equaline nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	07e0328e-1912-4f25-9e1e-9482d4665be0	2024-09-07	Warnings	Exact identifier application number: M012
Benadryl Allergy EXTRA STRENGTH	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	dd0a8069-18d8-5696-e053-2995a90a2f22	2024-09-06	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	PAI Holdings, LLC	88d0994c-4270-4408-8837-bd97510b2118	2024-09-06	Warnings	Exact identifier application number: M012
QCH Maximum Strength Mucus Relief 617	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association Inc.	a1c5c15e-0f3a-47d3-b9ed-1e0018417514	2024-09-06	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime Soft Chews	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	6ba64bbe-7599-406a-9187-737c0f8c1c2a	2024-09-05	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	344282fc-3bd1-4f49-9bd1-08c5a58d1f73	2024-09-05	Warnings	Exact identifier application number: M012
Equate Nasal	PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	95ef1819-edc3-4dda-8514-85b61538cc72	2024-09-04	Warnings	Exact identifier application number: M012
Up and up nasal	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	0c246c11-eadd-4ac6-bd58-5fdb151e06d6	2024-09-04	Warnings	Exact identifier application number: M012
Exchange Select Nasal	OXYMETAZOLINE HYDROCHLORIDE	Army & Air Force Exchange Service	aafa9163-f08e-48c9-9ca1-7b72f67d007d	2024-08-31	Warnings	Exact identifier application number: M012
nasal 12 hour	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	e9ee03db-a070-4c2b-ac61-7fd22bab2795	2024-08-31	Warnings	Exact identifier application number: M012
dg health nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	42b58928-e8e5-49e4-b49e-498d77d64fcd	2024-08-28	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HCL	Kroger Company	0a24d98a-5950-49de-8b77-ea880b08d2c5	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	96e018e2-e0b5-4802-a4a1-73a73d574082	2024-08-28	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HCL	Topco Associates LLC	b5434599-5485-4949-9d76-b1ef3ad17c1a	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	b15eb271-7842-495b-aa0f-9b20def86dc1	2024-08-28	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	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	d7aaf874-69ac-49cf-93be-6d4a38b9a557	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84415-012-01	84415001201	100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-012-01) / 5 mL in 1 CUP, UNIT-DOSE	2025-01-16	No	No	Current