FDA.reportPublic FDA data

Acne Treatment Gel

Product NDC
31720-301
11-digit product format
317200301
Labeler code
31720
Product ID
31720-301_47409d21-807e-7ccf-e063-6294a90ad5aa
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
S+
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-05
Substance
SALICYLIC ACID
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Treatment GelSALICYLIC ACIDS+688783fd-574e-40dd-a4cb-c59afdebcddc2025-12-31WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Acne Treatment Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui346298

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31720-301-08Acne Treatment Gel1 in 1 BOXGEL15
31720-301-08Acne Treatment Gel30 mL in 1 BOTTLEGEL305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31720-301ACNE TREATMENT GEL (SALICYLIC ACID) GEL [S+]4Current NDC, Legacy NDC, 2 package rows20250101_688783fd-574e-40dd-a4cb-c59afdebcddc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSN688783fd-574e-40dd-a4cb-c59afdebcddc5
346298salicylic acid 0.02 MG/MG Topical GelSCD688783fd-574e-40dd-a4cb-c59afdebcddc5
346298salicylic acid 2 % Topical GelSY688783fd-574e-40dd-a4cb-c59afdebcddc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31720-301-08317200301081 BOTTLE in 1 BOX (31720-301-08) / 30 mL in 1 BOTTLE1 bottle2022-12-050000-00-00NoNoCurrent