Acne Treatment

Product NDC
67234-007
11-digit product format
672340007
Labeler code
67234
Product ID
67234-007_1a6cc968-bb0b-438c-a780-cd96f466c28b
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
Natureplex, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-02
Substance
SALICYLIC ACID
Active strength
5 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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 TreatmentSALICYLIC ACIDNatureplex, LLC31b50718-cc60-460d-aad7-b9620970d4112026-01-29WarningsExact 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Additional Listing Data#

Finished product
Yes
Brand name base
Acne Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui252296

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67234-007-012025-01-30C16284748780-12cef2736-8653-d83d-e063-dadaa90ab31fAcne Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-007-01Acne Treatment42 g in 1 TUBEGEL424
67234-007-01Acne Treatment1 in 1 BOXGEL14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]1
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)INACTIVE INGREDIENTL605B5892VACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-007ACNE TREATMENT (SALICYLIC ACID) GEL [NATUREPLEX LLC]3Current NDC, Legacy NDC, 2 package rows20190808_31b50718-cc60-460d-aad7-b9620970d411.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252296salicylic acid 0.5 % Topical GelPSN31b50718-cc60-460d-aad7-b9620970d4114
252296salicylic acid 0.005 MG/MG Topical GelSCD31b50718-cc60-460d-aad7-b9620970d4114
252296salicylic acid 0.5 % Topical GelSY31b50718-cc60-460d-aad7-b9620970d4114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67234-007-01672340007011 TUBE in 1 BOX (67234-007-01) / 42 g in 1 TUBE1 tube2007-01-020000-00-00NoNoCurrent