FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Diphenhydramine HCl Oral Solution 25 mg/10 mLRising Pharma Holdings, Inc.2025-07-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-318-01Diphenhydramine HCl Oral Solution10 mL in 1 CUP, UNIT-DOSESOLUTION103
57237-318-11Diphenhydramine HCl Oral Solution100 in 1 BOX, UNIT-DOSESOLUTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-318DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20241019_8f0ba9e5-a31d-4d77-8155-c16c7e74edef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-318-01ML - Milliliter57237-31868c91723-6496-40f9-acb3-9533ba0ffe8412024-04-05
57237-318-11ML - Milliliter57237-3181e834ec8-4814-45ec-884d-f12e845892f712024-03-12

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 58 of 65 · 1,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Nighttime Sleep AidDIPHENYDRAMINE HYDROCHLORIDETARGET CORPORATIONfc7ed67f-bac9-f9ed-e053-6294a90ad9a12023-12-16WarningsExact identifier
unii: TC2D6JAD40
AllergyDIPHENHYDRAMINE HCL TABLETLil' Drug Store Products, Inc.e5339c39-1d66-b283-e053-2995a90a43172023-12-15WarningsExact identifier
unii: TC2D6JAD40
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Allergy, Circle KDIPHENHYDRAMINE HCL 25MG TABLETLil' Drug Store Products, Inc.d1f370ac-e7f4-baf7-e053-2995a90a1e502023-12-14WarningsExact identifier
unii: TC2D6JAD40
Sleep-Aid, Circle KDIPHENHYDRAMINE HCL CAPLET, 25MGLil' Drug Store Products, Inc.d3ad24c4-44ba-6451-e053-2a95a90a13392023-12-14WarningsExact identifier
unii: TC2D6JAD40
Circle K Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.a6a1e3d9-575c-4adf-beb6-c9719de55c672023-12-14WarningsExact identifier
unii: TC2D6JAD40
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsExact identifier
unii: 6DC9Q167V3
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: 6DC9Q167V3
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
CVS Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATECVS857af609-9dd7-a07a-e053-2991aa0ab6ba2023-12-11WarningsExact identifier
unii: TC2D6JAD40
Rite Aid Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERite Aid0c4170dd-e1fa-d549-e063-6394a90a5c232023-12-11WarningsExact identifier
unii: TC2D6JAD40
Westlake Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEWestlake HB Pharma LLC0c416ba6-b01f-0609-e063-6294a90ae2a12023-12-11WarningsExact identifier
unii: TC2D6JAD40
CVS Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS87473ace-d834-e43f-e053-2a95a90a819c2023-12-11WarningsExact identifier
unii: TC2D6JAD40
careone naproxen sodium pmDIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUMAmerican Sales Company16547905-59c0-4936-82e1-2d9f5935d8dd2023-12-11WarningsExact identifier
unii: TC2D6JAD40
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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