Diphenhydramine HCl Oral Solution

Product NDC: 57237-317
11-digit product format: 572370317
Labeler code: 57237
Product ID: 57237-317_1478d628-1d0d-491f-b68f-5281dd2ced76
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl Oral
Dosage form: SOLUTION
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: M009.50
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-12-15
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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Field, Values table
Field	Values
Unii	TC2D6JAD40
Rxcui	1049906

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-317-05	Diphenhydramine HCl Oral Solution	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5		3
57237-317-51	Diphenhydramine HCl Oral Solution	100 in 1 BOX, UNIT-DOSE	SOLUTION	100		3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-317-05	ML - Milliliter	57237-317	20cd5a07-8c36-4e9f-8aeb-f336568f6731	1	2024-04-05
57237-317-51	ML - Milliliter	57237-317	9dd085f1-b819-450f-b7d2-6e38ef6e7e3e	1	2024-03-12

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-317	DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 2 package rows	20241020_7406e4e4-3093-4cd1-80ce-93f7b6db2a87.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	7406e4e4-3093-4cd1-80ce-93f7b6db2a87	3
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	7406e4e4-3093-4cd1-80ce-93f7b6db2a87	3
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	7406e4e4-3093-4cd1-80ce-93f7b6db2a87	3
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	7406e4e4-3093-4cd1-80ce-93f7b6db2a87	3
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	7406e4e4-3093-4cd1-80ce-93f7b6db2a87	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
57237-317-05	57237031705	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
57237-317-51	57237031751	100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-317-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-317-05)		2023-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine HCl Oral Solution 12.5 mg/5 mL	Rising Pharma Holdings, Inc.	2025-07-01	HUMAN OTC DRUG LABEL	3