FDA.reportPublic FDA data

TopCare Chest Congestion Relief

Product NDC
36800-794
11-digit product format
368000794
Labeler code
36800
Product ID
36800-794_c04617b9-8e37-47df-9fad-cc3ad0c06c5f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
TOPCO ASSOCIATES LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-08-01
Substance
GUAIFENESIN
Active strength
400 mg/1
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
TopCare Chest Congestion Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui359601

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-794-502022-12-29C16284748780-1d6a99b39-e9fe-a426-e053-dadaa90af4c2Drug Facts
36800-794-502022-01-28C16284748780-1d6a99b39-e9fe-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-794-50TopCare Chest Congestion Relief1 in 1 CARTONTABLET13
36800-794-50TopCare Chest Congestion Relief50 in 1 BOTTLE, PLASTICTABLET503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-794-50EA - Each36800-79499f045f1-ec22-40a4-9a1d-c04522ef8a9a12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-794TOPCARE CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20241220_b8339617-17ce-4ad7-af38-399ecc74d864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359601guaiFENesin 400 MG Oral TabletPSNb8339617-17ce-4ad7-af38-399ecc74d8643
359601guaifenesin 400 MG Oral TabletSCDb8339617-17ce-4ad7-af38-399ecc74d8643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-794-50368000794501 BOTTLE, PLASTIC in 1 CARTON (36800-794-50) / 50 TABLET in 1 BOTTLE, PLASTIC2013-12-010000-00-00NoNoCurrent