Home NDC 52083-057 SUPRESS A
Product NDC 52083-057
11-digit product format 520830057
Labeler code 52083
Product ID 52083-057_5247bb80-1971-424b-8bf1-1f76465d6bac
Type HUMAN OTC DRUG
Nonproprietary name Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form SYRUP
Route ORAL
Labeler Kramer Novis
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-08-01
Substance DEXBROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 1; 10; 5 mg/mL; mg/mL; mg/mL
Pharmacologic classes Adrenergic alpha1-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-1 Adrenergic Agonist [EPC]
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52083-057-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52083-057-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52083-057-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52083-057-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52083-057-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52083-057-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52083-057-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52083-057-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 SUPRESS A
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXBROMPHENIRAMINE MALEATE 1 mg/mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BPA9UT29BS Internal UNII lookup 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1303797 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52083-057-01 SUPRESS A 30 mL in 1 BOTTLE, PLASTIC SYRUP 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXBROMPHENIRAMINE MALEATE ACTIVE INGREDIENT BPA9UT29BS SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 DEXBROMPHENIRAMINE ACTIVE MOIETY 75T64B71RP SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-057 SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS] 2 Current NDC, Legacy NDC, 1 package rows 20171229_f0bec5f5-4d76-471e-9024-557eba848b93.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52083-057-01 52083005701 30 mL in 1 BOTTLE, PLASTIC (52083-057-01) 30 ml 2012-08-01 0000-00-00 No No Current