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

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 Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1098647

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

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