Dexchlorpheniramine Maleate, Phenylephrine HCl

Product NDC
66576-080
11-digit product format
665760080
Labeler code
66576
Product ID
66576-080_ec8e1b86-9fd7-2534-e053-2a95a90a8bb3
Type
HUMAN OTC DRUG
Nonproprietary name
Dexchlorpheniramine Maleate, Phenylephrine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Syntho Pharmaceuticals Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-02
Marketing end
0000-00-00
Substance
DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44893bf2-1be4-4e68-8bc4-bbb0f543085eProduct name120180830

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66576-080-012024-01-30C16284748780-11030e365-44e5-111a-e063-dadaa90a10e2RYMED TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66576-080-01Dexchlorpheniramine Maleate, Phenylephrine HCl100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66576-080DEXCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL TABLET [SYNTHO PHARMACEUTICALS INC.]1Legacy NDC, 1 package rows20221110_fe6514a8-353f-4af4-89e7-1e6493f50224.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2184108dexchlorpheniramine maleate 2 MG / phenylephrine HCl 10 MG Oral TabletPSNfe6514a8-353f-4af4-89e7-1e6493f502241
2184108dexchlorpheniramine maleate 2 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDfe6514a8-353f-4af4-89e7-1e6493f502241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66576-080-0166576008001100 TABLET in 1 BOTTLE (66576-080-01) 100 tablet2022-11-020000-00-00NoNoCurrent