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 118 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efc46c9-a421-1998-e063-6394a90aeb64	2025-02-25	Warnings	Exact identifier application number: M012
Redicare Cough Drops Cherry Flavored	CHERRY FLAVORED MENTHOL COUGH DROPS	Redicare LLC	2efeaafa-ee96-37ee-e063-6394a90a9a4b	2025-02-25	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Genexa Inc.	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2025-02-20	Warnings	Exact identifier application number: M012
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	596ec923-56a0-4b6e-a69c-8d740feb75a2	2025-02-20	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	77a2dc96-73ee-4ca2-b1fe-406995802606	2025-02-19	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2	2025-02-19	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Bayer HealthCare LLC.	763a5334-a741-4678-9947-603776622450	2025-02-18	Warnings	Exact identifier application number: M012
Sof Skin Vaporizing Chest Rub and Cough Suppressant	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Viny Health and Beauty Inc	46ae16a4-b8a7-44de-ae1a-9bb503c15ea0	2025-02-18	Warnings	Exact identifier application number: M012
Pain Reliever PM	ACETAMINOPHEN DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	4897d1df-4fb3-46e2-bbf0-847e964dca0a	2025-02-18	Warnings	Exact identifier application number: M012
meijer EXTRA STRENGTH Pain Relief PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bee7e4f-1813-1bdf-e063-6294a90a6a32	2025-02-17	Warnings	Exact identifier application number: M012
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL	Kroger Company	a24f09d9-60f1-853a-e053-2a95a90ae1fa	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH COLD AND FLU	ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	FAMILY DOLLAR SERVICES	a7343bea-53cc-4621-e053-2a95a90a2a5f	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGHT DAY COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8ebccf-6813-2dca-e053-2a95a90a032b	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8f0465-1595-0b0f-e053-2a95a90a0081	2025-02-15	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	KROGER COMPANY	9bb7aaf0-6698-9a5c-e053-2a95a90a097c	2025-02-14	Warnings	Exact identifier application number: M012
Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H-E-B	db432947-fe02-79b2-e053-2a95a90af4a9	2025-02-14	Warnings	Exact identifier application number: M012
Halls Sugar Free Cherry	MENTHOL	Mondelez Global LLC	ea8dfe96-f6a4-4172-bf9e-ae3cf606ff50	2025-02-14	Warnings	Exact identifier application number: M012
Halls Sugar Free Watermelon	MENTHOL	Mondelez Global LLC	c4c090ca-f083-74e0-e053-2a95a90a9d60	2025-02-14	Warnings	Exact identifier application number: M012
Tukol Max Action	OXYMETAZOLINE HYDROCHLORIDE	Genomma Lab USA	73358103-43dc-4b11-9c89-9a6ba45bf1af	2025-02-14	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