FDA.reportPublic FDA data

Cough

Product NDC
0536-0825
11-digit product format
005360825
Labeler code
0536
Product ID
0536-0825_936410d5-2fd3-d458-e053-2995a90a8bc9
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Rugby Laboratories Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-12-04
Marketing end
2020-08-31
Substance
GUAIFENESIN
Active strength
100 mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-0825-85ML - Milliliter0536-0825c645f048-ddd4-434a-b295-174c2b149e9712012-07-24
0536-0825-97ML - Milliliter0536-0825a3e055cf-685e-4d80-9e5a-f03ee1595ad112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQCOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
GuaifenesinACTIVE MOIETY495W7451VQCOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
CaramelINACTIVE INGREDIENTT9D99G2B1RCOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPCOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
Corn SyrupINACTIVE INGREDIENT9G5L16BK6NCOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
MentholINACTIVE INGREDIENTL7T10EIP3ACOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3COUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYCOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUCOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RCOUGH (GUAIFENESIN) LIQUID [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN5379a585-584d-45f5-9113-dffc277d58761
310604guaifenesin 20 MG/ML Oral SolutionSCD5379a585-584d-45f5-9113-dffc277d58761
310604guaifenesin 100 MG per 5 ML Oral SolutionSY5379a585-584d-45f5-9113-dffc277d58761
310604guaifenesin 100 MG per 5 ML Oral SyrupSY5379a585-584d-45f5-9113-dffc277d58761
310604guaifenesin 200 MG per 10 ML Oral SolutionSY5379a585-584d-45f5-9113-dffc277d58761
310604guaifenesin 300 MG per 15 ML Oral SolutionSY5379a585-584d-45f5-9113-dffc277d58761
310604guaifenesin 400 MG per 20 ML Oral SolutionSY5379a585-584d-45f5-9113-dffc277d58761