FDA.reportPublic FDA data

NDC 57237-313-01 - Dextromethorphan HBr. and Guaifenesin

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
57237-313
Requested NDC
57237-313-01
Package NDCs from labels
57237-313-01, 57237-313-18
Manufacturer
Rising Pharma Holdings, Inc.
Effective date
2026-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dextromethorphan HBr. and Guaifenesin - Rising Pharma Holdings, Inc.Rising Pharma Holdings, Inc.2026-09-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-313-01Dextromethorphan HBr. and Guaifenesin10 mL in 1 CUP, UNIT-DOSESOLUTION105
57237-313-18Dextromethorphan HBr. and Guaifenesin80 in 1 BOX, UNIT-DOSESOLUTION805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-313DEXTROMETHORPHAN HBR. AND GUAIFENESIN SOLUTION [RISING PHARMA HOLDINGS, INC.]4Current NDC, 2 package rows20241013_e463e60f-d0db-4ee7-9713-ddf25aa38a43.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-313-01ML - Milliliter57237-313b4b7f776-ef79-4ae7-91fd-645b4e7d702c12023-07-06
57237-313-18ML - Milliliter57237-3131a032e32-c5d7-44b4-8e28-95a98c950ff812023-07-06

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 110 of 241 · 4,817 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens cough dmDEXTROMETHORPHAN POLISTIREXWalgreen Company317ab8e0-c329-4d4e-9fd0-4bff4e1504cd2025-11-20WarningsExact identifier
unii: 9D2RTI9KYH
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Mucus ReliefGUAIFENESINAMERIFOODS TRADING COMPANY3802d63d-7dba-50de-e063-6294a90acf7b2025-11-20WarningsExact identifier
unii: 495W7451VQ
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCf03090fa-f7e6-f53a-e053-2a95a90aa8192025-11-20WarningsExact identifier
unii: L7T10EIP3A
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INCff073e47-3107-e17e-e053-6294a90a58fa2025-11-20WarningsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCfc8a8f20-97ab-481e-e053-6394a90a35252025-11-20WarningsExact identifier
unii: L7T10EIP3A
MENTHOLMENTHOLSUNSET PAIN RELIEF ROLL-ON 3OZ934d4638-b47b-187d-e053-2995a90ae69d2025-11-20WarningsExact identifier
unii: L7T10EIP3A
Supress DX Pediatric DropsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISddb95436-7806-4086-af4d-18a6625b5c832025-11-20WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
FOOT PAIN RELIEF ROLL-ONLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd43edcea0-ab04-f368-e063-6294a90a817a2025-11-19WarningsExact identifier
unii: L7T10EIP3A
CVS Anti-ItchCAMPHOR, MENTHOLCVS87715662-c788-9a8d-e053-2a95a90acb532025-11-19WarningsExact identifier
unii: L7T10EIP3A
Walgreen Anti ItchCAMPHOR, MENTHOLWalgreensb4f47a8d-d4a6-9233-e053-2a95a90afd902025-11-19WarningsExact identifier
unii: L7T10EIP3A
Leader Anti-ItchCAMPHOR, MENTHOLLEADER/Cardinal Helath 110, Inc.9ca985c6-5017-0558-e053-2995a90a82022025-11-19WarningsExact identifier
unii: L7T10EIP3A
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF89f5f688-856f-f2df-e053-2995a90a73cf2025-11-19WarningsExact identifier
unii: L7T10EIP3A
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpc8594e10-661f-6ff3-e053-2995a90ab4fc2025-11-18WarningsExact identifier
unii: L7T10EIP3A
Mag 5 PT Cooling Formula Recovery CreamMENTHOLRENU LABORATORIES, LLCa45cde67-64ec-643b-e053-2a95a90a10b62025-11-18WarningsExact identifier
unii: L7T10EIP3A
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCa6f750c8-8738-4965-a3ad-612c246110562025-11-18WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
unii: XF417D3PSL
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDER J General Corporationd786ae07-ce57-44c7-9ba5-f4c87df115de2025-11-17WarningsExact identifier
unii: 9D2RTI9KYH
TYLENOL COLD AND FLUACETAMINPHENR J General Corporationb618877b-9dbc-4ba2-be2c-bf1922c646cc2025-11-17WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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