Urea

Product NDC: 42808-204
11-digit product format: 428080204
Labeler code: 42808
Product ID: 42808-204_ecad02ad-1a49-a269-e053-2a95a90a34a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Urea
Dosage form: GEL
Route: TOPICAL
Labeler: Exact-Rx, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-08-01
Marketing end: 0000-00-00
Substance: UREA
Active strength: 450 mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42808-204-28	ML - Milliliter	42808-204	70c3a140-7744-48a4-8f36-34d581b4e251	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
UREA	ACTIVE INGREDIENT	8W8T17847W	UREA GEL [EXACT-RX, INC.]	1
UREA	ACTIVE MOIETY	8W8T17847W	UREA GEL [EXACT-RX, INC.]	1
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	UREA GEL [EXACT-RX, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	UREA GEL [EXACT-RX, INC.]	1
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	UREA GEL [EXACT-RX, INC.]	1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	UREA GEL [EXACT-RX, INC.]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	UREA GEL [EXACT-RX, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	UREA GEL [EXACT-RX, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	UREA GEL [EXACT-RX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42808-204	UREA GEL [EXACT-RX, INC.]	9	Legacy NDC	20241225_b58e175d-60e8-4206-ac7a-c67b68ac80f0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42808-204-28	42808020428	1 BOTTLE, GLASS in 1 CARTON (42808-204-28) > 28 mL in 1 BOTTLE, GLASS	2011-08-01	0000-00-00	No	No	Current