FDA.reportPublic FDA data

NDC 50383-063-05 - 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
50383-063
Requested NDC
50383-063-05
Package NDCs from labels
50383-063-05, 50383-063-06, 50383-063-07, 50383-063-10, 50383-063-11, 50383-063-12, 50383-063-15, 50383-063-17, 50383-063-18
Manufacturer
Akorn | Akorn Operating Compnay LLC
Effective date
2022-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guaifenesin - Akorn | Akorn Operating Compnay LLCAkorn | Akorn Operating Compnay LLC2022-11-15HUMAN OTC DRUG LABEL
Guaifenesin - A-S Medication SolutionsA-S Medication Solutions2021-03-02HUMAN 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
50383-063-06Drug Facts
50383-063-07Drug Facts
50383-063-11Drug Facts
50383-063-12Drug Facts
50383-063-17Drug Facts
50383-063-18Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-063-05Guaifenesin5 mL in 1 CUP, UNIT-DOSESOLUTION55
50383-063-05Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-06Guaifenesin4 in 1 CASESOLUTION45
50383-063-07Guaifenesin10 in 1 CASESOLUTION105
50383-063-07Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-10Guaifenesin10 mL in 1 CUP, UNIT-DOSESOLUTION105
50383-063-10Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-11Guaifenesin4 in 1 CASESOLUTION45
50383-063-12Guaifenesin10 in 1 CASESOLUTION105
50383-063-12Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-15Guaifenesin10 in 1 TRAYSOLUTION105
50383-063-15Guaifenesin15 mL in 1 CUP, UNIT-DOSESOLUTION155
50383-063-17Guaifenesin4 in 1 CASESOLUTION45
50383-063-18Guaifenesin10 in 1 CASESOLUTION105
50383-063-18Guaifenesin10 in 1 TRAYSOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-063GUAIFENESIN SOLUTION [AKORN]5Legacy NDC, 15 package rows20221116_5cb704a7-301c-494e-948f-872ee0d5a289.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-063-05ML - Milliliter50383-06390f2681f-afb7-4e36-afb4-a505fa388a7d12013-03-03
50383-063-06ML - Milliliter50383-06317f28703-e107-4725-86df-a941a457143612013-04-01
50383-063-07ML - Milliliter50383-063fb73d3f2-e1d5-4211-be50-56b51942778412013-04-01
50383-063-10ML - Milliliter50383-063ac73897c-e6f2-4348-8bef-8f6b201e6c9412013-03-03
50383-063-11ML - Milliliter50383-0638d826061-57b2-48a1-80c2-219564aaf67512013-04-01
50383-063-12ML - Milliliter50383-06309d5fbbe-30aa-4c0a-af48-adc60f7f01ed12013-04-01
50383-063-15ML - Milliliter50383-063017a7ed6-c24b-421e-ba5f-5d3f0ad1514412013-03-03
50383-063-17ML - Milliliter50383-063f77887dd-e551-452d-9bca-23316d145c4412013-04-01
50383-063-18ML - Milliliter50383-063c10ed5b9-53c1-41f3-a2ef-2a35849dab0012013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
GUAIFENESINACTIVE MOIETY495W7451VQGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
HYPROMELLOSE 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP35GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RGUAIFENESIN 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 192 · 3,827 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
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)9a9c5c6b-94fe-484a-a879-12c29cbdefe42026-09-11WarningsExact identifier
unii: L7T10EIP3A
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
rxcui: 310604
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: 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
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
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: 495W7451VQ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 495W7451VQ
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsExact identifier
unii: 495W7451VQ
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 495W7451VQ
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
unii: 495W7451VQ
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRARITAN PHARMACEUTICALS INC4898b1c2-55ef-4589-982b-2279c01707e52026-09-08WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
unii: 495W7451VQ
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
unii: 495W7451VQ
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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