NDC 60432-608-04 - Promethazine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60432-608
Requested NDC
60432-608-04
Package NDCs from labels
60432-608-16, 60432-608-04
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2024-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP)ATLANTIC BIOLOGICALS CORP.2024-05-15HUMAN PRESCRIPTION DRUG LABEL
PROMETHAZINE HYDROCHLORIDE - A-S Medication SolutionsA-S Medication Solutions2021-04-16HUMAN PRESCRIPTION DRUG LABEL
PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP)Morton Grove Pharmaceuticals, Inc.2019-11-05HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Proficient Rx LPProficient Rx LP2019-01-01HUMAN PRESCRIPTION DRUG LABEL
PROMETHAZINE SYRUP PLAIN 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP)Physicians Total Care, Inc.2012-02-15HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Rebel Distributors CorpRebel Distributors Corp2011-01-04HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-608PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]5Legacy NDC20191106_3919fb0c-a0b6-470b-9ff2-63600bcbfbc9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-608-04ML - Milliliter60432-608fd51cd5b-22c5-4cb7-9fa4-9f67147df8da12012-07-24
60432-608-16ML - Milliliter60432-6087212e465-f5fa-4851-aa61-8e93656c290912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
sodium propionateINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
waterINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 189 · 3,774 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXbae9c9c1-107f-0fcb-e053-2a95a90a75b22026-09-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.