Diphenhydramine HCl Oral Solution

Product NDC: 69339-151
11-digit product format: 693390151
Labeler code: 69339
Product ID: 69339-151_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: 12.5 mg/5mL
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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

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
69339-151-05	Diphenhydramine HCl Oral Solution	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	6
69339-151-17	Diphenhydramine HCl Oral Solution	4 in 1 CASE	SOLUTION	4	6
69339-151-17	Diphenhydramine HCl Oral Solution	10 in 1 TRAY	SOLUTION	10	6
69339-151-19	Diphenhydramine HCl Oral Solution	10 in 1 TRAY	SOLUTION	10	6
69339-151-19	Diphenhydramine HCl Oral Solution	10 in 1 CASE	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
69339-151-05	ML - Milliliter	69339-151	6b763098-36a9-428b-b99e-2f9d64fd1606	1	2021-01-08
69339-151-17	ML - Milliliter	69339-151	84df1a81-2861-40c1-918e-dbfe443440d7	1	2021-01-08
69339-151-19	ML - Milliliter	69339-151	7ac1751c-0a0c-445d-8889-fbb8b51703b9	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69339-151	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 64 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dologesic DF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	55768b45-fd98-4779-85b6-6a50c628677e	2025-12-31	Warnings	Exact identifier application number: M012
Triponel	DEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCL	Llorens Pharmaceutical International Division, Inc.	e9a8deb4-0595-4f0f-ac15-f936f15aca88	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	805dc611-355a-4af5-bf19-464c3290c5c6	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	82f447f6-4f1b-4f56-9d7d-ea02adeea88c	2025-12-31	Warnings	Exact identifier application number: M012
Triponel	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	cc774d33-96ce-4992-ad30-3cb03b0d119d	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel SF	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	cb43b4df-5ccc-416e-abcd-98f079b3f2bb	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Cough Suppressant Expectorant	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	af71cdbc-33d6-4303-b494-d7321721d3be	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Llorens Pharmaceutical International Division, Inc.	63541753-de8d-42fe-a9b3-a5eac3fcdca4	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric Drops	GUAIFENESIN, PHENYLEPHRINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel DM Pediatric	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	d915eab8-013e-4ce3-b358-0d531e5ca1ba	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel-DM Pediatric	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	64e36b02-b5be-4d20-8818-cb5b23596671	2025-12-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f89a64-f4a4-f909-e053-2a91aa0ad44d	2025-12-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f65f59-7ea1-adce-e053-2991aa0a6f1f	2025-12-31	Warnings	Exact identifier application number: M012
Sugar Free Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f9e176-d87a-beed-e053-2991aa0aac20	2025-12-31	Warnings	Exact identifier application number: M012
Sugar Free Cherry Cough Drops	MENTHOL	Bestco Inc.	7858f380-bef7-3d30-e053-2a91aa0a7ea6	2025-12-31	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	BestCo Inc.	26a22cfd-395b-4ffb-e054-00144ff88e88	2025-12-31	Warnings	Exact identifier application number: M012
Limpia Pecho	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf3	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenges	BENZOCAINE	Bestco Inc.	737efd41-2d59-6013-e053-2a91aa0a6c63	2025-12-31	Warnings	Exact identifier application number: M012
Best Health Menthol Cough Drops	MENTHOL	Bestco LLC	dda66a3c-9006-ff1a-e053-2a95a90abfb3	2025-12-31	Warnings	Exact identifier application number: M012
Rynex DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Edwards Pharmaceuticals, Inc	7be2c282-24ba-4f19-9b14-872d3f5746a7	2025-12-31	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
69339-151-05	69339015105	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
69339-151-17	69339015117	4 TRAY in 1 CASE (69339-151-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05)	4 tray	2020-12-14	0000-00-00	No	No	Current
69339-151-19	69339015119	10 TRAY in 1 CASE (69339-151-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-151-05)	10 tray	2020-12-14	0000-00-00	No	No	Current