Altilan

Product NDC
53163-114
Requested package NDC
53163-114-16
11-digit product format
531630114
Labeler code
53163
Product ID
53163-114_e1639d1f-a2d7-4457-be55-180e33c7e2ca
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Phenylephrine HCl, Chlorpheniramine Maleate
Dosage form
LIQUID
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; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength
15 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53163-11453163-114-16DDiscontinued by firm2026-10-16

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53163-114-162020-12-23C16284748780-19d75b9cf-eda1-f424-e053-dadaa90a57ceb9ae54ee-4e6c-4282-8125-f0f2be3942fa
53163-114-162020-01-31C16284748780-19d75b9cf-eda1-f424-e053-dadaa90a57ceb9ae54ee-4e6c-4282-8125-f0f2be3942fa

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RALTILAN CL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53163-114-1653163011416473 mL in 1 BOTTLE (53163-114-16) 473 ml2015-03-010000-00-00NoNoCurrent