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 64 of 65 · 1,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GUNA-ALLERGY-PREV	AMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -	Guna spa	adae93c0-1de9-4e45-ab58-148171f0dc86	2018-12-21	Warnings	Exact identifier unii: 2968PHW8QP
Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	dbbc535f-515a-4d9b-b799-34e60f5230bb	2018-12-21	Warnings	Exact identifier unii: TC2D6JAD40
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier unii: 059QF0KO0R
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Time-Cap Labs, Inc	ed899055-0cbb-45bd-92c8-cbef2fc7c361	2018-12-17	Warnings	Exact identifier unii: TC2D6JAD40
IBUPROFEN, DIPHENHYDRAMINE HCL	IBUPROFEN, DIPHENHYDRAMINE HCL	Bionpharma Inc.	59a97c31-db90-48e1-ac1b-0f7026c8ec94	2018-11-09	Warnings	Exact identifier unii: TC2D6JAD40
Allergy	DIPHENHYDRAMINE HCL	Allegiant Health	c2823bad-540f-4662-8dcc-58e9f0d94efb	2018-11-07	Warnings	Exact identifier unii: TC2D6JAD40
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	Premier Value Alliance LLC	21afce91-afbe-4b38-a8a5-8775148835e8	2018-10-30	Warnings	Exact identifier unii: TC2D6JAD40
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Additox	TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	BioActive Nutritional, Inc.	319ee2fe-58e3-495e-bf0d-df201f6fbb1c	2018-07-18	Warnings	Exact identifier unii: 1Q73Q2JULR unii: Z8IX2SC1OH unii: A2I8C7HI9T
Nightime Sleep Aid	DIPHENHYDRAMINE	Velocity Pharma	9c44e54f-d8bc-4451-8382-40d2e8e03b42	2018-05-21	Warnings	Exact identifier unii: TC2D6JAD40
Pain Relief PM	ACETAMINOPHEN PM	Velocity Pharma	c1c1de91-6a54-4d91-93a9-b6be6d7c7dfb	2018-05-14	Warnings	Exact identifier unii: TC2D6JAD40
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Velocity Pharma LLC	73e4f21c-e5ec-42c9-9ec8-118479857057	2018-05-14	Warnings	Exact identifier unii: TC2D6JAD40
Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Velocity Pharma LLC	035454a1-d23b-4faf-8fac-a59fc77ce18c	2018-05-14	Warnings	Exact identifier unii: TC2D6JAD40
CVS Health Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	dbd8c221-8409-4851-a6b4-c9f5e8e346e7	2017-12-30	Warnings	Exact identifier rxcui: 1049906 unii: TC2D6JAD40
ACETAMINOPHEN PM	ACETAMINOPHEN PM	Advance Pharmaceutical Inc.	b172226e-8f2a-4d9c-b7c7-dd737b90463a	2017-12-22	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Advance Pharmaceutical Inc.	e1275cf5-94a7-4a15-be5c-81af95f8dd24	2017-12-22	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Advance Pharmaceutical Inc.	c80f9a4c-1055-45d2-8fde-5b57fad3c82a	2017-12-22	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Advance Pharmaceutical Inc.	4e66c626-607f-4558-ab2e-2dd9a25f7be4	2017-12-22	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals, Inc.	ab67121e-2477-47dd-a7ec-114453df3fd4	2017-10-30	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Advance Pharmaceutical Inc.	d1f51b7b-da65-4637-8199-f7d59e6dd1c1	2017-10-30	Warnings	Exact identifier unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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