Allergy Relief
Premier Value 44-599-Childrens
Approved
Approval ID
2df381f1-bace-46c6-831d-7f31c13f0fff
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
Chain Drug Consortium
DUNS: 101668460
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68016-051
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (11)
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: TC2D6JAD40
Classification: ACTIB
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT