FDA.reportPublic FDA data

DRx Choice

Product NDC
68163-743
11-digit product format
681630743
Labeler code
68163
Product ID
68163-743_3fef020a-9ccf-8f8a-e063-6394a90a376e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SYRUP
Route
ORAL
Labeler
Raritan Pharmaceuticals Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-15
Substance
GUAIFENESIN
Active strength
200 mg/10mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DRx Choice
Brand name suffix
Fruit Punch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310604

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-743-04DRx ChoiceFruit Punch118 mL in 1 BOTTLESYRUP1187
68163-743-04DRx ChoiceFruit Punch1 in 1 CARTONSYRUP17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-743DRX CHOICE FRUIT PUNCH (GUAIFENESIN) SYRUP [RARITAN PHARMACEUTICALS INC]6Current NDC, Legacy NDC, 2 package rows20241124_a19d7e1c-c04e-41c6-8af6-ecde96299216.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNa19d7e1c-c04e-41c6-8af6-ecde962992167
310604guaifenesin 20 MG/ML Oral SolutionSCDa19d7e1c-c04e-41c6-8af6-ecde962992167
310604guaifenesin 100 MG per 5 ML Oral SolutionSYa19d7e1c-c04e-41c6-8af6-ecde962992167
310604guaifenesin 100 MG per 5 ML Oral SyrupSYa19d7e1c-c04e-41c6-8af6-ecde962992167
310604guaifenesin 200 MG per 10 ML Oral SolutionSYa19d7e1c-c04e-41c6-8af6-ecde962992167
310604guaifenesin 300 MG per 15 ML Oral SolutionSYa19d7e1c-c04e-41c6-8af6-ecde962992167
310604guaifenesin 400 MG per 20 ML Oral SolutionSYa19d7e1c-c04e-41c6-8af6-ecde962992167

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68163-743-04681630743041 BOTTLE in 1 CARTON (68163-743-04) / 118 mL in 1 BOTTLE1 bottle2019-05-150000-00-00NoNoCurrent