Home NDC 53163-106-16 Igualtuss
Product NDC 53163-106
Requested package NDC 53163-106-16
11-digit product format 531630106
Labeler code 53163
Product ID 53163-106_f2f48593-234d-400f-b3f5-eaf31f98ba5f
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler Alternative Pharmacal Corporation
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-03-01
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 28 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53163-106 53163-106-16 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53163-106 53163-106-16 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 53163-106-16 Igualtuss 473 mL in 1 BOTTLE LIQUID 473 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1 WATER INACTIVE INGREDIENT 059QF0KO0R IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53163-106 IGUALTUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION] 6 Legacy NDC, 1 package rows 20241225_5499be5e-aa88-4376-9a77-4cfa3a4c168f.zip
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 53163-106-16 53163010616 473 mL in 1 BOTTLE (53163-106-16) 473 ml 2014-03-01 0000-00-00 No No Current