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 111 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walmart Inc.	24ff91f2-02db-56a2-e063-6394a90a31c9	2025-06-25	Warnings	Exact identifier application number: M012
Cough and Chest Congestion Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	e920b700-30d3-3266-e053-2a95a90a0639	2025-06-24	Warnings	Exact identifier application number: M012
good sense childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	L. Perrigo Company	2ffe0fbc-236d-417b-bbfd-5b9294f3c90a	2025-06-23	Warnings	Exact identifier application number: M012
Exchange Select Cough Drop Black Cherry Sugar Free	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	38034ad2-5eab-9caf-e063-6294a90abb8f	2025-06-20	Warnings	Exact identifier application number: M012
Herbal Cough Drops	HERBAL MENTHOL	Meijer, Inc.	380364be-4e52-fa52-e063-6394a90a713c	2025-06-20	Warnings	Exact identifier application number: M012
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED	Lil' Drug Store Products, Inc.	37c55543-e05e-2f7c-e063-6394a90a4534	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-Free	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	38049d29-f47e-9478-e063-6294a90aa2a4	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Menthol Sugar Free	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3804a271-9a11-848d-e063-6394a90af87d	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Menthol Sugar Free	MENTHOL	Army & Air Force Exchange Service	3805ef07-247d-0df7-e063-6394a90ac45b	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drop Black Cherry Sugar Free	MENTHOL	Army & Air Force Exchange Service	3805f8f5-562f-0ba8-e063-6394a90ac9d9	2025-06-20	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-Free	MENTHOL	Army & Air Force Exchange Service	3805f90e-bd89-128d-e063-6394a90afa01	2025-06-20	Warnings	Exact identifier application number: M012
TARGET Multi Symptom Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	TARGET CORPORATION	aebe3c15-53ef-46ea-af39-8c9b8114595f	2025-06-20	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Morning Star OTC	be95332d-a2e0-42e8-bfb3-8850d74990ff	2025-06-19	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Morning Star OTC	37e939c6-064b-3548-e063-6294a90a337d	2025-06-19	Warnings	Exact identifier application number: M012
Capron DM	DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE	Capital Pharmaceutical, LLC	cf778c5f-475e-4a86-a87c-2be1e665f5a5	2025-06-18	Warnings	Exact identifier application number: M012
Cough Out	GUAIFENESIN	Efficient Laboratories Inc.	fe4c3921-8d30-4cd6-ba90-9211b362a38a	2025-06-18	Warnings	Exact identifier application number: M012
Guaifenesin STRAWBERRY-BANANA FLAVOR	GUAIFENESIN	Innovida Pharmaeutique Corporation	1006906e-d6d7-4f49-92bf-3cb2d2cdbb16	2025-06-18	Warnings	Exact identifier application number: M012
Mucinex Sinus Max Clear and Cool	ACETAMINOPHEN AND GUAIFENESIN	RB Health (US) LLC	37de813a-54b7-672a-e063-6294a90a374e	2025-06-18	Warnings	Exact identifier application number: M012
childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4a1aeb41-a8fa-4116-8068-e11acd608e58	2025-06-18	Warnings	Exact identifier application number: M012
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIX	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED	Lil' Drug Store Products, Inc.	37c768f5-dabd-22d0-e063-6394a90af9e5	2025-06-17	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