FDA.reportPublic FDA data

Promethazine VC with Codeine

Product NDC
0603-1588
11-digit product format
006031588
Labeler code
0603
Product ID
0603-1588_02eac02b-67d5-463d-91e3-0ea7cb1b7ba4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA040660
Marketing category
ANDA
Marketing start
2006-12-07
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2019-12-31
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
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-1588-54ML - Milliliter0603-158870034e94-f232-4ba4-8542-5422f3cce7d812012-07-24
0603-1588-58ML - Milliliter0603-1588992cff7e-b077-4908-a827-c270ac8f1fa412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
CODEINEACTIVE MOIETYQ830PW7520PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3APROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]2
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
CODEINEACTIVE MOIETYQ830PW7520PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3APROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996757codeine phosphate 10 MG / phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNb21f10fb-0ced-4e57-b74f-0c9211491c1e2
996757codeine phosphate 2 MG/ML / phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDb21f10fb-0ced-4e57-b74f-0c9211491c1e2
996757codeine phosphate 10 MG / phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral SolutionSYb21f10fb-0ced-4e57-b74f-0c9211491c1e2
996757codeine phosphate 10 MG / phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN5c3c2c1b-ab52-410b-8c94-c125c6adb4d21
996757codeine phosphate 2 MG/ML / phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD5c3c2c1b-ab52-410b-8c94-c125c6adb4d21
996757codeine phosphate 10 MG / phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral SolutionSY5c3c2c1b-ab52-410b-8c94-c125c6adb4d21