FDA.reportPublic FDA data

NDC 50090-6585-00 - Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral

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
50090-6585
Requested NDC
50090-6585-00
Package NDCs from labels
50090-6585-0, 50090-6585-00
Manufacturer
A-S Medication Solutions
Effective date
2023-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DEXTROMETHORPHAN HYDROBROMIDE - A-S Medication SolutionsA-S Medication Solutions2023-08-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6585-0Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral118 mL in 1 BOTTLESOLUTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6585PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION [A-S MEDICATION SOLUTIONS]2Current NDC, 1 package rows20230814_9c3e0e87-b2f5-4a09-9db8-6d088d2a5f25.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6585-0ML - Milliliter50090-658541db1630-be8f-4b6b-b538-b7dfe8884e7312023-09-05

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 1 of 363 · 7,252 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB Cherry Cough DropsMENTHOLHEBc198e3c7-5ba7-ece6-e053-2995a90adb382026-10-27WarningsExact identifier
unii: L7T10EIP3A
Wet Ones Hand Sanitizer Mist Lavender BlossomETHYL ALCOHOLEdgewell Personal Care Brands LLCdae52e15-9161-c8d2-e053-2a95a90adb982026-09-29WarningsExact identifier
unii: 3K9958V90M
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 9D2RTI9KYH
SOUR LEMON HAND SANITIZER Pink Guava SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO0adfe188-4613-47dc-a9a3-5c9cfca781a82026-09-17WarningsExact identifier
unii: 3K9958V90M
hand sanitizer chocolate chip cookie scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO69d423f2-ff9f-48e0-a553-c7f4aaf37b292026-09-17WarningsExact identifier
unii: 3K9958V90M
12 hr relief cough dmDEXTROMETHORPHAN POLISTIREXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED03c44e2f-d6e3-4c78-9c9a-92d1708a62fe2026-09-16WarningsExact identifier
unii: 9D2RTI9KYH
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)9a9c5c6b-94fe-484a-a879-12c29cbdefe42026-09-11WarningsExact identifier
unii: L7T10EIP3A
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
OTTFFSS SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5b0991b6-59cc-59b3-e063-6394a90a76932026-09-09WarningsExact identifier
unii: L7T10EIP3A
THITFAM SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a78d096-4740-8dd4-e063-6294a90a651f2026-09-09WarningsExact identifier
unii: L7T10EIP3A
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
unii: L7T10EIP3A
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXbae9c9c1-107f-0fcb-e053-2a95a90a75b22026-09-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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