FDA.reportPublic FDA data

Altipres

Product NDC
53163-104
11-digit product format
531630104
Labeler code
53163
Product ID
53163-104_472ecc1a-795d-b592-e063-6394a90a1bb2
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Alternative Pharmacal Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 200; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53163-104-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53163-104-169bebd1f3094a…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
Altipres
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN200 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1098647Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5a43107-3eb8-46bb-87bd-20deafe28c3fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53163-104-162020-12-23C16284748780-19d75b9d0-1120-f424-e053-dadaa90a57ceAlt-Altipres 104
53163-104-162020-01-31C16284748780-19d75b9d0-1120-f424-e053-dadaa90a57ceAlt-Altipres 104

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53163-104-16Altipres473 mL in 1 BOTTLELIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53163-104-16ML - Milliliter53163-1046a9ca9ed-9029-49fd-8498-8cefec315e7312025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
GUAIFENESINACTIVE INGREDIENT495W7451VQALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
GUAIFENESINACTIVE MOIETY495W7451VQALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53163-104ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241228_c5a43107-3eb8-46bb-87bd-20deafe28c3f.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 17 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporationf1a4ee57-33a3-4791-a769-b208b38acb722026-07-13WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY Childrens Allergy ReliefDIPHENHYDRAMINE HCLAMERISOURCE BERGENc499574c-f32b-4608-bf8b-51ad44e357252026-07-13WarningsExact identifier
application number: M012
Good NeighborChildrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLAMERISOURCE BERGENf442c61b-7d2c-401c-b862-acbe2282927b2026-07-13WarningsExact identifier
application number: M012
SanatosMENTHOLPharmadel LLC5683b099-f029-2d08-e063-6394a90ad4822026-07-13WarningsExact identifier
application number: M012
Cold and Flu Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f673cdeb-4f8b-46b4-be92-c725d74abc552026-07-13WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEe4fca5ba-2d45-4c38-b0fd-297159d1705a2026-07-13WarningsExact identifier
application number: M012
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINAMERISOURCE BERGEN0269c0fd-0d8f-4264-9025-d4dcb3c45c602026-07-13WarningsExact identifier
application number: M012
Propolis Cooling Relief Cherry Cough DropsMENTHOL, UNSPECIFIED FORMBeekeeper's Naturals USA Inc7087566d-f24a-4508-aa25-7f42d055c43e2026-07-13WarningsExact identifier
application number: M012
Sinus Pressure and Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLRite Aid Corporation35bcf263-3296-4d9c-84c0-146a173d6e872026-07-13WarningsExact identifier
application number: M012
Good Neighbor Childrens Cough Relief Cherry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGENa8e2fd43-b801-41ae-8d79-8ecf4a7715432026-07-13WarningsExact identifier
application number: M012
Good Neighbor No Drip Nasal Mist Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEAMERISOURCE BERGEN7872aadd-b23c-431f-8048-24eece25ca2d2026-07-13WarningsExact identifier
application number: M012
Good Neighbor Dye Free Adult Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINAMERISOURCE BERGEN404a3521-8340-4476-a068-0e69cd0e514f2026-07-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab52026-07-13WarningsExact identifier
application number: M012
Good Neighbor Long Acting Cough Adult TussinDEXTROMETHORPHAN HBRAMERISOURCE BERGENdf3c76bd-bd5b-42d7-a5f1-560fd3cba6462026-07-13WarningsExact identifier
application number: M012
Good Neighbor Adult Tussin Mucus and chest congestionGUAIFENESINAMERISOURCE BERGEN97e9cd18-dd55-4a26-80e3-4c17b9e1a1e82026-07-13WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEAMERISOURCE BERGENa217ca8a-1c00-4816-bc26-cc0f71c80c902026-07-13WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company1ddc04fb-069c-44fe-814b-ba4f503c4be02026-07-10WarningsExact identifier
application number: M012
COUGH DROPS- menthol granuleMENTHOL GRANULEAnhui Jiuhe Health Industry Co., Ltd5351b943-5830-e4e7-e063-6394a90a5b662026-07-10WarningsExact identifier
application number: M012
ValuMeds Nasal Decongestant PE PhenylephrinePHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.3f284420-87c1-4c17-99e5-bc569bf9d45f2026-07-10WarningsExact identifier
application number: M012
Severe Congestion and Cough Multi-Symptom Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy707eb066-cdfc-444b-833a-9d6d133d48e42026-07-10WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098647dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSNc5a43107-3eb8-46bb-87bd-20deafe28c3f6
1098647dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCDc5a43107-3eb8-46bb-87bd-20deafe28c3f6
1098647dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSYc5a43107-3eb8-46bb-87bd-20deafe28c3f6
1098647dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSYc5a43107-3eb8-46bb-87bd-20deafe28c3f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53163-104-1653163010416473 mL in 1 BOTTLE (53163-104-16) 473 ml2013-05-010000-00-00NoNoCurrent