FDA.reportPublic FDA data

Differin Epiduo

Product NDC
0299-4908
Requested package NDC
0299-4908-40
11-digit product format
002994908
Labeler code
0299
Product ID
0299-4908_30e41f9e-c736-40e3-bb96-df21c26d23fc
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene and Benzoyl Peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA220736
Marketing category
NDA
Marketing start
2026-05-22
Substance
ADAPALENE; BENZOYL PEROXIDE
Active strength
1; 25 mg/g; mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220736-001DIFFERIN EPIDUOADAPALENE; BENZOYL PEROXIDE0.1%;2.5%GEL / TOPICALRLD, RS2026-05-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N220736-001DIFFERIN EPIDUO0.1%;2.5%GEL / TOPICALRLD, RS2026-05-2284e616aacf4f…
2026-08-18 06:07:402026-07N220736-001DIFFERIN EPIDUO0.1%;2.5%GEL / TOPICALRLD, RS2026-05-22caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220736-001DIFFERIN EPIDUO0.1%;2.5%GEL / TOPICALRLD, RS2026-05-22a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Differin Epiduo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE1 mg/g
BENZOYL PEROXIDE25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1L4806J2QFInternal UNII lookup
W9WZN9A0GMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
829539Internal RxNorm lookup
2743622Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae3f8cd9-9046-4b69-b80f-3e9d4468ba7fAvailable on FDA.report

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
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-4908-00Differin Epiduo2 g in 1 TUBEGEL21
0299-4908-10Differin Epiduo15 g in 1 BOTTLE, PUMPGEL151
0299-4908-10Differin Epiduo1 in 1 CARTONGEL11
0299-4908-40Differin Epiduo45 g in 1 BOTTLE, PUMPGEL451
0299-4908-40Differin Epiduo1 in 1 CARTONGEL11

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Differin EpiduoADAPALENE AND BENZOYL PEROXIDEGalderma Laboratories, L.P.ae3f8cd9-9046-4b69-b80f-3e9d4468ba7f2026-05-20WarningsExact identifier
application applno (NDA): 220736
application number: NDA220736
ndc (package): 0299-4908-40
ndc (product): 0299-4908
ndc11 (package): 00299490840

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelPSNae3f8cd9-9046-4b69-b80f-3e9d4468ba7f1
2743622DIFFERIN EPIDUO 0.1 % / 2.5 % Topical GelPSNae3f8cd9-9046-4b69-b80f-3e9d4468ba7f1
2743622adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Differin Epiduo]SBDae3f8cd9-9046-4b69-b80f-3e9d4468ba7f1
829539adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical GelSCDae3f8cd9-9046-4b69-b80f-3e9d4468ba7f1
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelSYae3f8cd9-9046-4b69-b80f-3e9d4468ba7f1
2743622Differin Epiduo (adapalene 0.1 % / benzoyl peroxide 2.5 % ) Topical GelSYae3f8cd9-9046-4b69-b80f-3e9d4468ba7f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0299-4908-40002994908401 BOTTLE, PUMP in 1 CARTON (0299-4908-40) / 45 g in 1 BOTTLE, PUMP2026-05-22NoNoCurrent