Home NDC 53163-108-01 Altidesp
Product NDC 53163-108
Requested package NDC 53163-108-01
11-digit product format 531630108
Labeler code 53163
Product ID 53163-108_20ae625d-ca76-40d2-8cfd-dced5f7058a3
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler Alternative Pharmacal Corporation
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-03-01
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 mg/mL; mg/mL; mg/mL
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 53163-108 53163-108-01 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53163-108 53163-108-01 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 53163-108-01 Altidesp 30 mL in 1 BOTTLE SOLUTION/ DROPS 30 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 SACCHARIN CALCIUM INACTIVE INGREDIENT 5101OP7P2I ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53163-108 ALTIDESP (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [ALTERNATIVE PHARMACAL CORPORATION] 6 Legacy NDC, 1 package rows 20241225_21a356f3-e14d-4b6f-9772-a0932ddeb048.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 53163-108-01 53163010801 30 mL in 1 BOTTLE (53163-108-01) 30 ml 2015-03-01 0000-00-00 No No Current