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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67234-007-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67234-007-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67234-007-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67234-007-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67234-007-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67234-007-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67234-007-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67234-007-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67234-007-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Acne Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252296Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31b50718-cc60-460d-aad7-b9620970d411Available on FDA.report

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

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 51 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic AcidSALICYLIC ACIDNew Milani Group, LLCc2d43609-8a7a-4e54-8e8c-66115948dba22023-12-12WarningsExact identifier
application number: M006
Differin Daily Deep Cleanser with BPOBENZOYL PEROXIDEGalderma Laboratories, L.P.192b231b-51f1-457c-9a82-ef75671c0d342023-12-11WarningsExact identifier
application number: M006
SkinCeuticals Silymarin CF Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incaa439d77-7ba5-4699-8e8b-3bba35f5094d2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control MoisturizerSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION04df2f5d-77f0-4553-9d8c-3f10628736ae2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Inc4acae53c-3250-4703-83ac-f158562926c62023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body ScrubSALICYLIC ACIDGalderma Laboratories, L.P.b1e9f483-80ad-49f1-974e-4732bacd96392023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONa2369870-cf81-4ebd-a354-858212d67d0e2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Daily Deep CleansingSALICYLIC ACIDL'Oreal USA Products Inc0db3a8cb-7691-4772-9f7d-15de66098e2e2023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body WashSALICYLIC ACIDGalderma Laboratories, L.P.b280351f-02d4-4456-85b5-905e835968482023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing BodySALICYLIC ACIDGalderma Laboratories, L.P.ce4d1074-5f74-4ad7-9535-2737f5fff24f2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Incb7d0d094-6a5b-4776-9f13-1f8d305424762023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Deep CleansingSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONb61a3f74-a588-47f4-b4a5-c8f97f98d9dd2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incc6f5e9a4-c938-4c44-ace7-a9688b227d592023-12-11WarningsExact identifier
application number: M006
Clarifying TonerSALICYLIC ACIDAllure Labs0c07e6e9-18c1-20da-e063-6294a90aa3c82023-12-08WarningsExact identifier
application number: M006
Acne Advanced Clarifying HydratorSALICYLIC ACIDEminence Organic Skin Care Ltd.b710cc36-f589-4116-a0a2-c6966ebebbf22023-12-08WarningsExact identifier
application number: M006
Foaming CleanserSALICYLIC ACIDAllure Labs0bf4c2d8-2fbf-a1c4-e063-6294a90ac1302023-12-07WarningsExact identifier
application number: M006
CLEAROGEN 3BENZOYL PEROXIDEAllure Labs0bdf9f38-5763-a4d0-e063-6394a90a41dc2023-12-06WarningsExact identifier
application number: M006
REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOEBENZOYL PEROXIDETopiderm, Inc.ea9a32c4-3795-4718-9394-bac69091c7322023-12-04WarningsExact identifier
application number: M006
Acne Advanced Treatment SystemSALICYLIC ACIDEminence Organic Skin Care Ltd.9acf53a6-10f1-470d-b270-3a0203cf89c02023-12-02WarningsExact identifier
application number: M006
Cetaphil Gentle Clear BPO Acne CleanserBENZOYL PEROXIDEGalderma Laboratories, L.P.6397f20f-d69f-47e4-a123-4cc7e1abfcad2023-11-29WarningsExact identifier
application number: M006

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