FDA.reportPublic FDA data

NDC 50383-062-10 - 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
50383-062
Requested NDC
50383-062-10
Package NDCs from labels
50383-062-05, 50383-062-06, 50383-062-07, 50383-062-10, 50383-062-11, 50383-062-12
Manufacturer
Akorn | Akorn Operating Company LLC
Effective date
2022-03-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dextromethorphan HBr and Guaifenesin - Akorn | Akorn Operating Company LLCAkorn | Akorn Operating Company LLC2022-03-08HUMAN OTC DRUG LABEL
Dextromethorphan HBr and Guaifenesin - A-S Medication SolutionsA-S Medication Solutions2020-01-18HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
50383-062-06Drug Facts
50383-062-07Drug Facts
50383-062-11Drug Facts
50383-062-12Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-062-05Dextromethorphan HBr and Guaifenesin10 in 1 TRAYSOLUTION105
50383-062-05Dextromethorphan HBr and Guaifenesin5 mL in 1 CUP, UNIT-DOSESOLUTION55
50383-062-06Dextromethorphan HBr and Guaifenesin4 in 1 CASESOLUTION45
50383-062-07Dextromethorphan HBr and Guaifenesin10 in 1 CASESOLUTION105
50383-062-07Dextromethorphan HBr and Guaifenesin10 in 1 TRAYSOLUTION105
50383-062-10Dextromethorphan HBr and Guaifenesin10 mL in 1 CUP, UNIT-DOSESOLUTION105
50383-062-10Dextromethorphan HBr and Guaifenesin10 in 1 TRAYSOLUTION105
50383-062-11Dextromethorphan HBr and Guaifenesin4 in 1 CASESOLUTION45
50383-062-12Dextromethorphan HBr and Guaifenesin10 in 1 TRAYSOLUTION105
50383-062-12Dextromethorphan HBr and Guaifenesin10 in 1 CASESOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-062DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [AKORN]5Legacy NDC, 10 package rows20220309_ed74de02-852a-4dfe-8462-fa22044a2258.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-062-05ML - Milliliter50383-0623b76b61d-6899-435b-8d7b-f22839e108c312013-03-03
50383-062-06ML - Milliliter50383-06233711fd0-1dcd-49bd-96e0-872094c2444e12013-04-01
50383-062-07ML - Milliliter50383-062c141208d-32c2-42be-8255-dd4390799d5812013-04-01
50383-062-10ML - Milliliter50383-06260cbe226-4e0b-4d6e-886c-ca1d2e0e621b12013-03-03
50383-062-11ML - Milliliter50383-062374a31ec-bcfd-4172-9491-42fd98a7fbd112013-04-01
50383-062-12ML - Milliliter50383-062a6540397-da10-4136-aaad-7a30c5d09a9212013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQDEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQDEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
HYPROMELLOSE 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP35DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ADEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROMETHORPHAN HBR AND GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2

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 239 · 4,775 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302026-10-01WarningsExact identifier
unii: 495W7451VQ
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 9D2RTI9KYH
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
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
unii: 495W7451VQ
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
unii: 495W7451VQ
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsExact identifier
unii: 495W7451VQ
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
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsExact identifier
unii: 495W7451VQ
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 495W7451VQ
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 9D2RTI9KYH
unii: 495W7451VQ
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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