Home NDC 36800-794 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 36800-794-50 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 36800-794-50 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 36800-794-50 bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TopCare Chest Congestion Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 359601 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-794-50 TopCare Chest Congestion Relief 1 in 1 CARTON TABLET 1 3 36800-794-50 TopCare Chest Congestion Relief 50 in 1 BOTTLE, PLASTIC TABLET 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-794 TOPCARE CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [TOPCO ASSOCIATES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241220_b8339617-17ce-4ad7-af38-399ecc74d864.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 36800-794-50 36800079450 1 BOTTLE, PLASTIC in 1 CARTON (36800-794-50) / 50 TABLET in 1 BOTTLE, PLASTIC 2013-12-01 0000-00-00 No No Current