Diphenhydramine HCl Oral Solution

Product NDC: 69339-152
11-digit product format: 693390152
Labeler code: 69339
Product ID: 69339-152_6c998d25-3573-4c6b-822a-1c16eeddd642
Type: HUMAN OTC DRUG
Nonproprietary name: diphenhydramine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Natco Pharma USA LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-14
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: 2027-12-31
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: 2027-12-31

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
54b64354-ac10-42ff-a53d-96cef933a91a	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
69339-152-01	Diphenhydramine HCl Oral Solution	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	6
69339-152-17	Diphenhydramine HCl Oral Solution	4 in 1 CASE	SOLUTION	4	6
69339-152-17	Diphenhydramine HCl Oral Solution	10 in 1 TRAY	SOLUTION	10	6
69339-152-19	Diphenhydramine HCl Oral Solution	10 in 1 CASE	SOLUTION	10	6
69339-152-19	Diphenhydramine HCl Oral Solution	10 in 1 TRAY	SOLUTION	10	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69339-152-01	ML - Milliliter	69339-152	647442f3-f072-4ea8-b0e3-43cbbc52d609	1	2021-01-08
69339-152-17	ML - Milliliter	69339-152	b053be9b-804f-4cfe-b7b9-6cfde7ecb26f	1	2021-01-08
69339-152-19	ML - Milliliter	69339-152	da851f3d-9a4a-431d-9e74-005b6279e354	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69339-152	DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [NATCO PHARMA USA LLC]	6	Current NDC, Legacy NDC, 5 package rows	20231102_54b64354-ac10-42ff-a53d-96cef933a91a.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 122 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough Drops	MENTHOL	The Kroger CO	f6da2e02-42c7-1ede-e053-6394a90aff5f	2025-02-09	Warnings	Exact identifier application number: M012
MUCOSA DM	GUAIFENESIN DEXTROMETHORPHAN	TIME CAP LABORATORIES, INC.	62c1f4aa-6571-414c-9a58-31e107b7db97	2025-02-08	Warnings	Exact identifier application number: M012
Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	2d95d5a4-34dc-e195-e063-6394a90a39da	2025-02-07	Warnings	Exact identifier application number: M012
Halls Sugar Free Honey Lemon	MENTHOL	Mondelez Global LLC	5d56ccd2-1c28-4750-9454-44809091ad2f	2025-02-05	Warnings	Exact identifier application number: M012
SanaTos Mucus Relief Cold Toddlers	DEXTROMETHORPHAN HBR, GUAIFENESIN	Pharmadel LLC	60672feb-1421-651e-e053-2a91aa0af41d	2025-02-04	Warnings	Exact identifier application number: M012
SofSkin Vaporizing Chest Rub and Cough Suppressant	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Viny Health and Beauty Inc	34626cf5-64fc-15c0-e063-6294a90aa310	2025-02-04	Warnings	Exact identifier application number: M012
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	CVS PHARMACY, INC	17922df7-7867-4300-bd99-55aee7b60606	2025-02-04	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	f4b8ff54-47b5-4d18-bf4e-b101abb22a24	2025-02-03	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	f40bfdfc-1cb4-4604-9790-fb8d1d5173c6	2025-01-31	Warnings	Exact identifier application number: M012
NIGHTIME COLD AND FLU	NIGHTIME COLD AND FLU	TARGET CORP	9dee9b92-eac9-b07d-e053-2995a90a0602	2025-01-31	Warnings	Exact identifier application number: M012
Rugby Chest Congestion Relief DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Bryant Ranch Prepack	7b23faa9-40c8-4cea-b9fb-487cce2664af	2025-01-31	Warnings	Exact identifier application number: M012
BENADRYL Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	224ba2a3-1a93-29c8-e063-6394a90a9bef	2025-01-30	Warnings	Exact identifier application number: M012
Extra Strength Nite-Time Pain Relief	430R WALGREENS ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HCL 25 MG TABLET	WALGREENS	c25cff5a-93f5-62aa-e053-2a95a90aa7b4	2025-01-30	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WALGREENS	dbf5c814-4e69-13ac-e053-2a95a90a49a3	2025-01-30	Warnings	Exact identifier application number: M012
Mucus DM Fast Max Day Cold and Flu and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	WALGREENS	f3770976-de73-52b8-e053-2995a90aad4f	2025-01-30	Warnings	Exact identifier application number: M012
Dextromethorphan HBr and Guaifenesin Oral Solution	DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION	KESIN PHARMA CORPORATION	284eae44-81bc-400c-e063-6394a90af446	2025-01-30	Warnings	Exact identifier application number: M012
Vapor Shower	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	26c82bc3-5753-4d56-96a4-a3f9c8c267d0	2025-01-30	Warnings	Exact identifier application number: M012
Vapor Shower	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	8095b211-8ae7-44e5-b89a-b7f730e28d51	2025-01-30	Warnings	Exact identifier application number: M012
Vapor Shower	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2cf2f35b-5d59-e3ff-e063-6294a90a9b45	2025-01-30	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy, Daytime	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Rite Aid Corporation	8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5	2025-01-30	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	54b64354-ac10-42ff-a53d-96cef933a91a	6
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	54b64354-ac10-42ff-a53d-96cef933a91a	6
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	54b64354-ac10-42ff-a53d-96cef933a91a	6
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	54b64354-ac10-42ff-a53d-96cef933a91a	6
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	54b64354-ac10-42ff-a53d-96cef933a91a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69339-152-01	69339015201	10 mL in 1 CUP, UNIT-DOSE	10 ml					Historical
69339-152-17	69339015217	4 TRAY in 1 CASE (69339-152-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-152-01)	4 tray	2020-12-14	0000-00-00	No	No	Current
69339-152-19	69339015219	10 TRAY in 1 CASE (69339-152-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-152-01)	10 tray	2020-12-14	0000-00-00	No	No	Current