FDA.reportPublic FDA data

Clophed

Product NDC
49963-630
11-digit product format
499630630
Labeler code
49963
Product ID
49963-630_11108f5d-d9ea-498e-ba87-a6eff07dfa7f
Type
HUMAN OTC DRUG
Nonproprietary name
Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Portal Pharmaceutical
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-05-28
Marketing end
0000-00-00
Substance
CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
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

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
49963-630-042019-10-29C16284748780-1960f7f55-c545-8e05-e053-dbdaa90a074aChlophed
49963-630-152019-10-29C16284748780-1960f7f55-c545-8e05-e053-dbdaa90a074aChlophed

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49963-630-04Clophed118 mL in 1 BOTTLELIQUID1182
49963-630-15Clophed15 mL in 1 BOTTLELIQUID152

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Chlophedianol HydrochlorideACTIVE INGREDIENT69QQ58998YCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
GuaifenesinACTIVE INGREDIENT495W7451VQCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
ChlophedianolACTIVE MOIETY42C50P12APCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
GuaifenesinACTIVE MOIETY495W7451VQCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
PhenylephrineACTIVE MOIETY1WS297W6MVCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Citric AcidINACTIVE INGREDIENT2968PHW8QPCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
SorbitolINACTIVE INGREDIENT506T60A25RCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2
WaterINACTIVE INGREDIENT059QF0KO0RCLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49963-630CLOPHED (CHLOPHEDIANOL HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL]2Legacy NDC, 2 package rows20110105_49370e61-f9db-47d0-a43f-b1797b077867.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1048075chlophedianol HCl 12.5 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG in 5 mL Oral SolutionPSN49370e61-f9db-47d0-a43f-b1797b0778672
1048075chlophedianol hydrochloride 2.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD49370e61-f9db-47d0-a43f-b1797b0778672
1048075chlophedianol HCl 12.5 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY49370e61-f9db-47d0-a43f-b1797b0778672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49963-630-0449963063004118 mL in 1 BOTTLE118 mlHistorical
49963-630-154996306301515 mL in 1 BOTTLE15 mlHistorical