FDA.reportPublic FDA data

NDC 50383-087-05 - Guaiatussin AC Sugar Free

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
50383-087
Requested NDC
50383-087-05
Package NDCs from labels
50383-087-16, 50383-087-04, 50383-087-05, 50383-087-07, 50383-087-10, 50383-087-12
Manufacturer
Cardinal Health 107, LLC
Effective date
2023-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guaiatussin AC Sugar Free - Cardinal Health 107, LLCCardinal Health 107, LLC2023-11-15HUMAN OTC DRUG LABEL
Guaiatussin AC - A-S Medication SolutionsA-S Medication Solutions2023-02-04HUMAN OTC DRUG LABEL
Guaiatussin AC Sugar Free - Akorn Operating Company LLCAkorn Operating Company LLC2022-10-14HUMAN OTC DRUG LABEL
Drug FactsPreferred Pharmaceuticals, Inc.2020-06-08HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
50383-087-04Drug Facts
50383-087-07Drug Facts
50383-087-12Drug Facts
50383-087-16Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-087-04Guaiatussin ACSugar Free118 mL in 1 BOTTLELIQUID1188
50383-087-05Guaiatussin ACSugar Free5 mL in 1 CUP, UNIT-DOSELIQUID58
50383-087-07Guaiatussin ACSugar Free10 in 1 CASELIQUID108
50383-087-07Guaiatussin ACSugar Free10 in 1 TRAYLIQUID108
50383-087-10Guaiatussin ACSugar Free10 mL in 1 CUP, UNIT-DOSELIQUID108
50383-087-12Guaiatussin ACSugar Free10 in 1 TRAYLIQUID108
50383-087-12Guaiatussin ACSugar Free10 in 1 CASELIQUID108
50383-087-16Guaiatussin ACSugar Free473 mL in 1 BOTTLELIQUID4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-087GUAIATUSSIN AC SUGAR FREE (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [AKORN OPERATING COMPANY LLC]8Legacy NDC, 8 package rows20221018_b920eba2-27f2-402c-a7c9-d0988977965c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-087-04ML - Milliliter50383-08729494081-d566-4f6d-8538-414cea30439812012-07-24
50383-087-05ML - Milliliter50383-087527380f2-ab5d-4c06-9067-7faccb7b4caf12013-12-02
50383-087-07ML - Milliliter50383-08741adca2b-ffe8-4268-9221-bbcfc9746c3412013-12-02
50383-087-10ML - Milliliter50383-087a0b09403-6e9e-405f-b8b2-1815a522ccc812013-12-02
50383-087-12ML - Milliliter50383-0877ef59b38-bc41-4d6b-866a-eddac3fec54112013-12-02
50383-087-16ML - Milliliter50383-087916d3d41-fe50-4fdf-bcd2-173e682bfafe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
GUAIFENESINACTIVE INGREDIENT495W7451VQGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
GUAIFENESINACTIVE MOIETY495W7451VQGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
CARAMELINACTIVE INGREDIENTT9D99G2B1RGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95GUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RGUAIATUSSIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) LIQUID [HI-TECH PHARMACAL CO., INC.]4

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 237 · 4,732 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
hand sanitizer chocolate chip cookie scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO69d423f2-ff9f-48e0-a553-c7f4aaf37b292026-09-17WarningsExact identifier
unii: 3K9958V90M
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: 495W7451VQ
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsExact identifier
unii: 495W7451VQ
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
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
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
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
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

Reported adverse events (FAERS/openFDA)#

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