FDA.reportPublic FDA data

Libera Tos

Product NDC
60840-0200
11-digit product format
608400200
Labeler code
60840
Product ID
60840-0200_d91b4832-d7d8-4485-8491-714e3de35e81
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
RockHealth, Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-11-01
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60840-0200-12019-11-27C16284748780-19855e2a2-3c36-60a7-e053-dbdaa90a05bdLibera Tos Diabetic
60840-0200-22019-11-27C16284748780-19855e2a2-3c36-60a7-e053-dbdaa90a05bdLibera Tos Diabetic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60840-0200-1Libera Tos118 mL in 1 BOTTLELIQUID1182
60840-0200-2Libera Tos178 mL in 1 BOTTLELIQUID1782

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
GUAIFENESINACTIVE INGREDIENT495W7451VQLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
GUAIFENESINACTIVE MOIETY495W7451VQLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
ALOEINACTIVE INGREDIENTV5VD430YW9LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
CARAMELINACTIVE INGREDIENTT9D99G2B1RLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
GINGERINACTIVE INGREDIENTC5529G5JPQLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ALIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RLIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60840-0200LIBERA TOS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ROCKHEALTH, INC]2Legacy NDC, 2 package rows20131217_56027d3b-3412-4c99-b3bb-62a623824184.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN56027d3b-3412-4c99-b3bb-62a6238241842
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD56027d3b-3412-4c99-b3bb-62a6238241842
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY56027d3b-3412-4c99-b3bb-62a6238241842
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY56027d3b-3412-4c99-b3bb-62a6238241842
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY56027d3b-3412-4c99-b3bb-62a6238241842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
60840-0200-160840020001118 mL in 1 BOTTLE118 mlHistorical
60840-0200-260840020002178 mL in 1 BOTTLE178 mlHistorical