Palatos Expectorante

Product NDC
53149-2000
11-digit product format
531492000
Labeler code
53149
Product ID
53149-2000_9c51c482-adea-4b02-b5fd-ac52ddbdd22c
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
All Pharma, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
GUAIFENESIN
Active strength
100 mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-2000-6Palatos Expectorante1 in 1 BOXLIQUID13
53149-2000-6Palatos Expectorante177 mL in 1 BOTTLELIQUID1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-2000PALATOS EXPECTORANTE (GUAIFENESIN) LIQUID [ALL PHARMA, LLC]3Legacy NDC, 2 package rows20220517_d7786e19-8809-469c-8e84-761f231268e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSNd7786e19-8809-469c-8e84-761f231268e13
310604guaifenesin 20 MG/ML Oral SolutionSCDd7786e19-8809-469c-8e84-761f231268e13
310604guaifenesin 100 MG per 5 ML Oral SolutionSYd7786e19-8809-469c-8e84-761f231268e13
310604guaifenesin 100 MG per 5 ML Oral SyrupSYd7786e19-8809-469c-8e84-761f231268e13
310604guaifenesin 200 MG per 10 ML Oral SolutionSYd7786e19-8809-469c-8e84-761f231268e13
310604guaifenesin 300 MG per 15 ML Oral SolutionSYd7786e19-8809-469c-8e84-761f231268e13
310604guaifenesin 400 MG per 20 ML Oral SolutionSYd7786e19-8809-469c-8e84-761f231268e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53149-2000-6531492000061 BOTTLE in 1 BOX (53149-2000-6) > 177 mL in 1 BOTTLE1 bottle2019-01-010000-00-00NoNoCurrent