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 98 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Menthol Drops Dollar General Severe Honey Lemon 45ct MENTHOL Dollar General Corporation 0ea61a4c-690a-4349-9952-cc17fb1f0671 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Dollar General Menthol 30ct MENTHOL Dollar General Corporation 892092cc-5a1c-4309-baf9-a040888d3577 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Dollar General Menthol 80ct MENTHOL Dollar General Corporation 773f4ad2-6c91-431f-ad3d-c0e53e7ca918 2025-10-08 Warnings Exact identifier application number: M012 Menthol Drops Dollar General Severe 45ct MENTHOL Dollar General Corporation 13c7d3b1-12ac-4931-877c-728d3d89942c 2025-10-08 Warnings Exact identifier application number: M012 Menthol Drops Dollar General Severe Honey Lemon 45ct MENTHOL Dollar General Corporation d0c878f0-a737-4583-9847-834af70e7d6f 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Freegells Strawberry 30ct MENTHOL R.L. ALBERT & SON, INC dc077c36-c403-4b83-894a-e9922e928841 2025-10-08 Warnings Exact identifier application number: M012 Cough Drops Freegells Strawberry 30ct MENTHOL RL Albert & Son Inc. 2ea760f3-df50-4c46-a43d-d5ed07f421a5 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Honey Lemon 200ct MENTHOL RL Albert & Son Inc. 3ac08274-08d9-4dab-b09a-6e297948a25a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Honey Lemon 30ct MENTHOL RL Albert & Son Inc. 8114e1a2-728d-4489-a494-f28a5e7d9bb3 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 30ct MENTHOL RL Albert & Son Inc. 0c2e594a-cdf8-4595-bda6-0ebc19ac3850 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 200ct MENTHOL R.L. ALBERT & SON, INC f62b7f75-3275-46c9-880c-64148d0dce59 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL R.L. ALBERT & SON, INC 15917bfb-f660-4a12-bdcc-5b4a96e0e1d0 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL RL Albert & Son Inc. 92c54c53-c8bb-4576-abae-715a2f3878bf 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol 80ct MENTHOL RL Albert & Son Inc. c96cc162-5908-4990-9dc1-3ce912844274 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 30ct MENTHOL R.L. ALBERT & SON, INC bac77712-6197-4b30-a5f8-9b99eb9d7b5a 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL R.L. ALBERT & SON, INC 6842d766-ade6-40b2-831b-f4feac25c6db 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry 80ct MENTHOL RL Albert & Son Inc. 9f324ca1-0e2a-47e3-997e-2aaa68a85751 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 30ct MENTHOL R.L. ALBERT & SON, INC 2063a013-aa0b-465d-b04f-cfe2e70d749f 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 200ct MENTHOL R.L. ALBERT & SON, INC cd81488c-74d8-48d9-9c73-ff662a5cd4cd 2025-10-08 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon 80ct MENTHOL R.L. ALBERT & SON, INC 61deea94-d0a9-4563-926b-53f255a7c425 2025-10-08 Warnings Exact identifier application number: M012
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