NDC 57237-318-01 - Diphenhydramine HCl Oral Solution

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 57237-318
Requested NDC: 57237-318-01
Package NDCs from labels: 57237-318-01, 57237-318-11
Manufacturer: Rising Pharma Holdings, Inc.
Effective date: 2025-07-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Diphenhydramine HCl Oral Solution 25 mg/10 mL	Rising Pharma Holdings, Inc.	2025-07-01	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-318-01	Diphenhydramine HCl Oral Solution	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10		3
57237-318-11	Diphenhydramine HCl Oral Solution	100 in 1 BOX, UNIT-DOSE	SOLUTION	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-318	DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [RISING PHARMA HOLDINGS, INC.]	2	Current NDC, 2 package rows	20241019_8f0ba9e5-a31d-4d77-8155-c16c7e74edef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-318-01	ML - Milliliter	57237-318	68c91723-6496-40f9-acb3-9533ba0ffe84	1	2024-04-05
57237-318-11	ML - Milliliter	57237-318	1e834ec8-4814-45ec-884d-f12e845892f7	1	2024-03-12

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 55 of 65 · 1,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Cold and Cough childrens	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	11652e8a-2242-4449-8a41-a8e75509025e	2024-02-20	Warnings	Exact identifier unii: TC2D6JAD40
Nighttime sleep aid Maximum Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	40e73317-5126-4961-8f28-60899ffbec5a	2024-02-20	Warnings	Exact identifier unii: TC2D6JAD40
Nighttime sleep aid Maximum Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	2424fb95-06e2-49e7-aea0-7797a37aef4d	2024-02-20	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	d9f650b5-3c27-17cf-e053-2995a90af48a	2024-02-12	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy, Inc	f5b609e1-e63b-2e3b-e053-2995a90a76b9	2024-02-12	Warnings	Exact identifier unii: TC2D6JAD40
Itch stopping Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	11368823-d4af-a536-e063-6294a90a7a2e	2024-02-12	Warnings	Exact identifier unii: TC2D6JAD40
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	01e7dddb-755c-4745-b701-edcdb6209064	2024-02-06	Warnings, Adverse reactions	Exact identifier unii: TC2D6JAD40
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	fe7cd1f2-9b00-4ded-99c2-8a152c71093c	2024-02-06	Warnings, Adverse reactions	Exact identifier unii: TC2D6JAD40
Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Safetec of America, Inc.	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	2024-02-04	Warnings	Exact identifier unii: TC2D6JAD40
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	4daca846-8511-4303-9e6c-9469f7f260ba	2024-02-02	Warnings	Exact identifier unii: TC2D6JAD40
Sterile Water	STERILE WATER	Chartwell RX, LLC	3681eeaa-807a-47ca-9fbc-61c2b682800a	2024-02-01		Exact identifier unii: 059QF0KO0R
good sense allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	L. Perrigo Company	2cfa69b4-e33f-442a-a6df-b021b041da14	2024-02-01	Warnings	Exact identifier unii: TC2D6JAD40
Sterile Water	WATER	A-S Medication Solutions	dba87371-31d2-47c2-ab83-89aabce4b184	2024-01-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
THERAFLU POWERPODS NIGHTTIME SEVERE COLD	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	39f9feef-4bf2-4f10-9fff-22bbb1d8a471	2024-01-30	Warnings	Exact identifier unii: TC2D6JAD40
Kroger Nighttime Sleep Aid CAPLET	DIPHENHYDRAMINE HYDROCHLORIDE	The Kroger Co.	f0f3f58d-9457-4697-98e6-ef52d350cf67	2024-01-29	Warnings	Exact identifier unii: TC2D6JAD40
THERAFLU NIGHTTIME SEVERE COLD AND COUGH	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	5f7f6f70-0f36-4541-89f2-d953259cdb1e	2024-01-28	Warnings	Exact identifier unii: TC2D6JAD40
Allergy Relief	ALLERGY RELIEF	Good Sense	bb709377-7bb3-4931-a2b6-2443aee07c12	2024-01-26	Warnings	Exact identifier unii: TC2D6JAD40
BSS	BALANCED SALT SOLUTION	Alcon Laboratories, Inc.	4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea	2024-01-25	Warnings, Adverse reactions	Exact identifier unii: 1Q73Q2JULR
basic care naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Amazon.com Services LLC	7beed9e7-816b-494b-93fa-9caf10aa3834	2024-01-24	Warnings	Exact identifier unii: TC2D6JAD40
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	721bfee2-0d3d-4d8b-beee-1ea83064d1c8	2024-01-23	Warnings	Exact identifier unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.