FDA.reportPublic FDA data

Tussin CF

Product NDC
67510-0506
11-digit product format
675100506
Labeler code
67510
Product ID
67510-0506_e039c466-6788-4aaf-b15b-275c2cfe796e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Kareway Product, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-26
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0506-42019-10-29C16284748780-1960f7f55-c58d-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0506-4Tussin CF1 in 1 BOXLIQUID11
67510-0506-4Tussin CF120 mL in 1 BOTTLELIQUID1201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554TUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0506TUSSIN CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [KAREWAY PRODUCT, INC.]1Legacy NDC, 2 package rows20110923_5f8dffc8-ffee-4ca9-b37d-40ccad2ba86a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044949dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSN5f8dffc8-ffee-4ca9-b37d-40ccad2ba86a1
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD5f8dffc8-ffee-4ca9-b37d-40ccad2ba86a1
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY5f8dffc8-ffee-4ca9-b37d-40ccad2ba86a1
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSY5f8dffc8-ffee-4ca9-b37d-40ccad2ba86a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67510-0506-4675100506041 in 1 BOXHistorical