Home NDC 53163-101 Altipres-B
Product NDC 53163-101
11-digit product format 531630101
Labeler code 53163
Product ID 53163-101_47437518-7fd7-d058-e063-6394a90a752e
Type HUMAN OTC DRUG
Nonproprietary name BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form LIQUID
Route ORAL
Labeler Alternative Pharmacal Corporation
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-11-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE
Active strength 20; 10; 4 mg/5mL; mg/5mL; mg/5mL
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 · 4 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 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53163-101-16 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53163-101-16 9bebd1f3094a…5416666fcb17…
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 Altipres-B
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL BROMPHENIRAMINE MALEATE 4 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup IXA7C9ZN03 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1148155 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 53163-101-16 Altipres-B 473 mL in 1 BOTTLE LIQUID 473 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BROMPHENIRAMINE MALEATE ACTIVE INGREDIENT IXA7C9ZN03 ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 BROMPHENIRAMINE ACTIVE MOIETY H57G17P2FN ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53163-101 ALTIPRES-B (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 6 Current NDC, Legacy NDC, 1 package rows 20241228_fd00c41d-0580-4177-afaa-60bb12ca5a09.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 53163-101-16 53163010116 473 mL in 1 BOTTLE (53163-101-16) 473 ml 2012-11-01 0000-00-00 No No Current