EPSOLAY

Product NDC
0299-5890
11-digit product format
002995890
Labeler code
0299
Product ID
0299-5890_71106ed6-4cab-48f2-a552-f512a9ada02e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA214510
Marketing category
NDA
Marketing start
2022-05-09
Marketing end
2026-06-30
Substance
BENZOYL PEROXIDE
Active strength
50 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EPSOLAY

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui308693, 2600969

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-5890-00EPSOLAY3 g in 1 BOTTLE, PUMPCREAM35
0299-5890-30EPSOLAY30 g in 1 BOTTLE, PUMPCREAM305
0299-5890-30EPSOLAY1 in 1 BOXCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5890-00GM - Gram0299-5890fbdf7b9d-338b-49a4-9931-aa2ebbc173b112022-07-06
0299-5890-30GM - Gram0299-5890eb884b61-e7df-41bb-bd1b-eb75bbddce4d12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5890EPSOLAY (BENZOYL PEROXIDE) CREAM [GALDERMA LABORATORIES, L.P.]4Current NDC, Legacy NDC, 3 package rows20241114_507e2cd7-6bcf-4606-bc62-694d64537701.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308693benzoyl peroxide 5 % Topical CreamPSN507e2cd7-6bcf-4606-bc62-694d645377015
2600969EPSOLAY 5 % Topical CreamPSN507e2cd7-6bcf-4606-bc62-694d645377015
2600969benzoyl peroxide 50 MG/ML Topical Cream [Epsolay]SBD507e2cd7-6bcf-4606-bc62-694d645377015
308693benzoyl peroxide 50 MG/ML Topical CreamSCD507e2cd7-6bcf-4606-bc62-694d645377015
308693benzoyl peroxide 5 % Topical CreamSY507e2cd7-6bcf-4606-bc62-694d645377015
2600969Epsolay 5 % Topical CreamSY507e2cd7-6bcf-4606-bc62-694d645377015
2600969Epsolay 50 MG/ML Topical CreamSY507e2cd7-6bcf-4606-bc62-694d645377015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5890-00002995890003 g in 1 BOTTLE, PUMP (0299-5890-00) 3 g2022-05-092026-06-30YesNoCurrent
0299-5890-30002995890301 BOTTLE, PUMP in 1 BOX (0299-5890-30) / 30 g in 1 BOTTLE, PUMP2022-05-272026-06-30NoNoCurrent