Home NDC 36800-799-26 Topcare Tussin DM Max
Product NDC 36800-799
Requested package NDC 36800-799-26
11-digit product format 368000799
Labeler code 36800
Product ID 36800-799_12594966-4c6d-4660-a028-bda20d499f89
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form SUSPENSION
Route ORAL
Labeler Topco Associates LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-04-16
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20 mg/10mL; mg/10mL
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 MENTHOL INACTIVE INGREDIENT L7T10EIP3A TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [TOPCO ASSOCIATES LLC] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-799-26 36800079926 1 BOTTLE in 1 CARTON (36800-799-26) > 118 mL in 1 BOTTLE 1 bottle 2010-04-16 0000-00-00 No No Current