PRO-CHLO

Product NDC
66594-321
11-digit product format
665940321
Labeler code
66594
Product ID
66594-321_43da4965-15ef-4716-95a6-ea67a636ae43
Type
HUMAN OTC DRUG
Nonproprietary name
Chlophedianol Hydrochloride, Phenylephrine Hydrochloride, Pyrilamine Maleate
Dosage form
LIQUID
Route
ORAL
Labeler
Pro-Pharma, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-12-12
Marketing end
0000-00-00
Substance
CHLOPHEDIANOL HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength
13 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66594-321-012019-11-13C16284748780-197449f38-ca22-f6ea-e053-dbdaa90aa703PRO-CHLO LIQUID
66594-321-162019-11-13C16284748780-197449f38-ca22-f6ea-e053-dbdaa90aa703PRO-CHLO LIQUID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66594-321-01PRO-CHLO30 mL in 1 BOTTLELIQUID301
66594-321-16PRO-CHLO473 mL in 1 BOTTLELIQUID4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66594-321-16ML - Milliliter66594-32153d029ae-2f64-49df-892e-6546506be45b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlophedianol HydrochlorideACTIVE INGREDIENT69QQ58998YPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
Pyrilamine MaleateACTIVE INGREDIENTR35D29L3ZAPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
ChlophedianolACTIVE MOIETY42C50P12APPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
PhenylephrineACTIVE MOIETY1WS297W6MVPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
PyrilamineACTIVE MOIETYHPE317O9TLPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
SorbitolINACTIVE INGREDIENT506T60A25RPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RPRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66594-321PRO-CHLO (CHLOPHEDIANOL HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [PRO-PHARMA, LLC]1Legacy NDC, 2 package rows20120214_c767a626-a3ce-490c-a511-00749784acab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1192685chlophedianol HCl 12.5 MG / phenylephrine HCl 5 MG / pyrilamine maleate 12.5 MG in 5 mL Oral SolutionPSNc767a626-a3ce-490c-a511-00749784acab1
1192685chlophedianol hydrochloride 2.5 MG/ML / phenylephrine hydrochloride 1 MG/ML / pyrilamine maleate 2.5 MG/ML Oral SolutionSCDc767a626-a3ce-490c-a511-00749784acab1
1192685chlophedianol hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG / pyrilamine maleate 12.5 MG per 5 ML Oral SolutionSYc767a626-a3ce-490c-a511-00749784acab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66594-321-016659403210130 mL in 1 BOTTLE30 mlHistorical
66594-321-1666594032116473 mL in 1 BOTTLE473 mlHistorical