Home NDC 53163-113 Altituss
Product NDC 53163-113
11-digit product format 531630113
Labeler code 53163
Product ID 53163-113_472ea5ae-3e91-42e3-e063-6294a90a4505
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Alternative Pharmacal Corporation
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-03-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 15; 150 mg/7.5mL; mg/7.5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 53163-113-16 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 53163-113-16 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 Altituss
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/7.5mL GUAIFENESIN 150 mg/7.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 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 996520 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 53163-113-16 Altituss 473 mL in 1 BOTTLE LIQUID 473 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) INACTIVE INGREDIENT R33S7TK2EP ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53163-113 ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 6 Current NDC, Legacy NDC, 1 package rows 20241228_e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44.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 73 of 177 · 3,534 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 53163-113-16 53163011316 473 mL in 1 BOTTLE (53163-113-16) 473 ml 2015-03-01 0000-00-00 No No Current