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 110 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACTINEL PEDIATRIC	DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL	ACTIPHARMA, LLC	6bb92d74-4893-40b8-af58-eb307155e876	2025-07-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	776b7c67-56c7-420c-82b2-9a176d998396	2025-07-08	Warnings	Exact identifier application number: M012
ACTICON	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	847014ab-86ae-40c5-8e7f-f1ddea14f1b3	2025-07-08	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN 400 MG	Cabinet Health, Inc.	26a51b0e-039c-663c-e063-6394a90ad384	2025-07-07	Warnings	Exact identifier application number: M012
EZ Nite Sleep	DIPHENHYDRAMINE HCL	Safeway, Inc.	21a68c60-3005-43bb-8ec5-7982239c93f8	2025-07-07	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	8188b66a-5405-4e62-bde6-63ebc1f22b16	2025-07-04	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer, Inc.	fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a	2025-07-03	Warnings	Exact identifier application number: M012
Cabinet Allergy Relief Refill Diphenhydramine HCI	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	d47553a4-ca15-4f0a-8177-d743a5c39cc5	2025-07-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Advanced Rx LLC	20e164b8-4cbc-cf3f-e063-6394a90a9d0c	2025-07-02	Warnings	Exact identifier application number: M012
24/7 Life Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT	Lil' Drug Store Products, Inc.	f03430d4-8dbb-4fc0-e053-2a95a90a119d	2025-07-02	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	KJD Pharma Private Limited	b109249a-a0be-41bd-b6ce-ef621b588ddc	2025-07-02	Warnings	Exact identifier application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	2025-07-01	Warnings	Exact identifier application number: M012
WALGREENS Dye Free Chidrens Allergy Chews	DIPHENHYDRAMINE HCL	WALGREENS CO.	cc2fdc6b-8319-47c8-b036-37dbd65d5833	2025-06-30	Warnings	Exact identifier application number: M012
WALGREENS Dye Free Chidrens Allergy Chews	DIPHENHYDRAMINE HCL	WALGREENS CO.	91c369b0-8620-4764-a85d-a86402d9489c	2025-06-30	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGel	DIPHENHYDRAMINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	bb9a82b1-ea7a-4d10-bc00-05013e83c4d3	2025-06-30	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS, LLC	202f0661-461c-0333-e063-6294a90a96b5	2025-06-28	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	CVS Pharmacy	f038b713-0721-2bb5-e053-2a95a90a7842	2025-06-26	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGel	DIPHENHYDRAMINE HYDROCHLORIDE	NUVICARE LLC	bb728ceb-8eb0-4192-a8b0-742756819a05	2025-06-26	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC	7aee34b5-1583-4a8a-8ffb-b17ef2722ac1	2025-06-25	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREENS	c0270298-e7c5-e500-e053-2995a90aed23	2025-06-25	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