Diphenhydramine HCl

Product NDC: 60687-830
11-digit product format: 606870830
Labeler code: 60687
Product ID: 60687-830_1c81b131-ccf6-49a7-e063-6394a90a9695
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: American Health Packaging
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-08-04
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/10mL
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/10mL

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
b94feeb6-f33f-410d-a9b0-776b1ccf34a9	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
60687-830-08	Diphenhydramine HCl	3 in 1 CASE	SOLUTION	3	1
60687-830-42	Diphenhydramine HCl	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	1
60687-830-48	Diphenhydramine HCl	10 in 1 TRAY	SOLUTION	10	1
60687-830-56	Diphenhydramine HCl	10 in 1 CASE	SOLUTION	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-830-08	ML - Milliliter	60687-830	74bb08dd-ec95-4d39-844d-b922a7ef398d	1	2024-08-12
60687-830-42	ML - Milliliter	60687-830	232e4cae-e85d-4615-bb8a-a476310e3203	1	2024-08-12
60687-830-56	ML - Milliliter	60687-830	62c97559-f178-49b1-a955-80145c3413d1	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-830	DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AMERICAN HEALTH PACKAGING]	1	Current NDC, 4 package rows	20240807_b94feeb6-f33f-410d-a9b0-776b1ccf34a9.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 11 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORIGINAL Nasal PUMP MIST No Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	ac27fd75-4fe4-433c-a434-2dac16c895c7	2026-08-07	Warnings	Exact identifier application number: M012
Winco Foods Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HYDROCHLORIDE	WINCO FOODS, LLC	a1367804-37c9-4906-858f-8feeb748d8d3	2026-08-07	Warnings	Exact identifier application number: M012
Severe Congestion Nasal Anti-Drip Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	a09c2d02-334a-4840-b2d0-327121cec994	2026-08-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Intense Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	03aa43fd-4962-4c2c-9edd-e422a629a0e3	2026-08-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f311b56f-b959-4070-9b23-82c642dd98b8	2026-08-06	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	2ed25f69-89ef-4c50-946a-7e7b9df1ca8a	2026-08-06	Warnings	Exact identifier application number: M012
Eucamint	MENTHOL, CAMPHOR	Indiana Botanic Gardens	d79bc8de-9efb-4996-a55c-accda0f8edb2	2026-08-06	Warnings	Exact identifier application number: M012
NICOTINE GUM	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	4e88dab4-8e13-f074-e063-6394a90a3908	2026-08-06	Warnings	Exact identifier application number: M012
Oneoo Nicotine Gum (Mint)	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	54b1329b-b422-29a5-e063-6294a90a8780	2026-08-06	Warnings	Exact identifier application number: M012
Sine Aid PEAK MISERY	OXYMETAZOLINE HYDROCHLORIDE	Infirst Healthcare Inc.	586a2a14-7048-0c8b-e063-6394a90a65b7	2026-08-06	Warnings	Exact identifier application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc	b745f45d-2042-4daa-9932-241836d7734b	2026-08-06	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	NUVICARE LLC	6713fdff-0e4e-4a9d-b218-34f786339c57	2026-08-06	Warnings	Exact identifier application number: M012
Daytime Cold, Nighttime Cold multi-symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	3b462a5d-d48b-4b73-b5d4-d7944730bbdd	2026-08-06	Warnings	Exact identifier application number: M012
TOPCARE DAY TIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	d1b89d17-b3b9-4133-88a3-8cd7c4efafa9	2026-08-05	Warnings	Exact identifier application number: M012
Sinufrin Quick Relief Decongestant	SINUFRIN	Neilmed pharmaceuticals Inc.	0c36a34e-462d-713c-e063-6294a90a1776	2026-08-05	Warnings	Exact identifier application number: M012
No Drip	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	e9b799ad-9164-7f30-e053-2a95a90a00c5	2026-08-05	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	507284c3-cad9-d65c-e063-6394a90a58a8	2026-08-05	Warnings	Exact identifier application number: M012
cough and cold relief HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	United Natural Foods, Inc. dba UNFI	90482e7a-d7c7-4127-972d-5ee55e55ed1c	2026-08-04	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreen Company	78edeb7a-4712-4f04-9d76-d5b2d20ce76d	2026-08-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Better Living Brands, LLC	33f34aa2-3b37-4e51-8428-4a12708aa064	2026-08-04	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	b94feeb6-f33f-410d-a9b0-776b1ccf34a9	1
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	b94feeb6-f33f-410d-a9b0-776b1ccf34a9	1
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	b94feeb6-f33f-410d-a9b0-776b1ccf34a9	1
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	b94feeb6-f33f-410d-a9b0-776b1ccf34a9	1
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	b94feeb6-f33f-410d-a9b0-776b1ccf34a9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-830-08	60687083008	3 TRAY in 1 CASE (60687-830-08) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-830-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-830-42)	3 tray	2024-08-04	No	No	Current
60687-830-42	60687083042	10 mL in 1 CUP, UNIT-DOSE	10 ml				Historical
60687-830-48	60687083048	10 in 1 TRAY					Historical
60687-830-56	60687083056	10 TRAY in 1 CASE (60687-830-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-830-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-830-42)	10 tray	2024-08-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine HCl Oral Solution, USP	American Health Packaging	2024-08-04	HUMAN OTC DRUG LABEL	1