FDA.reportPublic FDA data

Altituss

Product NDC
53163-113
Requested package NDC
53163-113-16
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53163-11353163-113-16IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53163-11353163-113-16IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…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
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/7.5mL
GUAIFENESIN150 mg/7.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53163-113-162020-12-23C16284748780-19d75b9cf-f956-f424-e053-dadaa90a57ceAlt-Altituss 113
53163-113-162020-01-31C16284748780-19d75b9cf-f956-f424-e053-dadaa90a57ceAlt-Altituss 113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53163-113-16Altituss473 mL in 1 BOTTLELIQUID4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53163-113-16ML - Milliliter53163-1135b9c9fd1-aced-4796-834e-5d4f8062a3cb12025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
GUAIFENESINACTIVE INGREDIENT495W7451VQALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
GUAIFENESINACTIVE MOIETY495W7451VQALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53163-113ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]6Current NDC, Legacy NDC, 1 package rows20241228_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 1 of 191 · 3,814 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
application number: M012
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
application number: M012
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNe4ac96f5-2a3a-42a8-8db5-80de4dcdbd447
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDe4ac96f5-2a3a-42a8-8db5-80de4dcdbd447
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYe4ac96f5-2a3a-42a8-8db5-80de4dcdbd447
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYe4ac96f5-2a3a-42a8-8db5-80de4dcdbd447
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYe4ac96f5-2a3a-42a8-8db5-80de4dcdbd447

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53163-113-1653163011316473 mL in 1 BOTTLE (53163-113-16) 473 ml2015-03-010000-00-00NoNoCurrent