Home NDC 52083-625-16 ABATUSS DMX
Product NDC 52083-625
Requested package NDC 52083-625-16
11-digit product format 520830625
Labeler code 52083
Product ID 52083-625_a0f9bf55-af76-4bbb-bb71-648d1f9a0da3
Type HUMAN OTC DRUG
Nonproprietary name DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form LIQUID
Route ORAL
Labeler Kramer Novis
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-05-25
Marketing end 0000-00-00
Substance DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 1 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXCHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT B10YD955QW ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 DEXCHLORPHENIRAMINE ACTIVE MOIETY 3Q9Q0B929N ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-625 ABATUSS DMX (DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [KRAMER NOVIS] 3 Legacy NDC 20221029_6d54ef1e-6722-43f9-a0a7-14a786160b04.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52083-625-16 52083062516 1 BOTTLE in 1 CARTON (52083-625-16) > 473 mL in 1 BOTTLE 1 bottle 2014-05-25 0000-00-00 No No Current