FDA.reportPublic FDA data

Acne Dots

Product NDC
78936-401
11-digit product format
789360401
Labeler code
78936
Product ID
78936-401_16596715-b3c1-1bcd-e063-6294a90a4046
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Hangzhou Caring Cleaning Commodity Co., Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-04-19
Substance
SALICYLIC ACID
Active strength
5 mg/1000mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID5 mg/1000mg

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
1994404Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16596715-b3c0-1bcd-e063-6294a90a4046Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78936-401-01Acne Dots17 mg in 1 PATCHPATCH171
78936-401-10Acne Dots40 in 1 BOXPATCH401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78936-401ACNE DOTS (SALICYLIC ACID) PATCH [HANGZHOU CARING CLEANING COMMODITY CO., LTD]1Current NDC, 2 package rows20240420_16596715-b3c0-1bcd-e063-6294a90a4046.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne DotsSALICYLIC ACIDHangzhou Caring Cleaning Commodity Co., Ltd16596715-b3c0-1bcd-e063-6294a90a40462024-04-19WarningsExact identifier
ndc (product): 78936-401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1994404salicylic acid 0.5 % Medicated PatchPSN16596715-b3c0-1bcd-e063-6294a90a40461
1994404salicylic acid 0.005 MG/MG Medicated PatchSCD16596715-b3c0-1bcd-e063-6294a90a40461
1994404salicylic acid 0.5 % Medicated PatchSY16596715-b3c0-1bcd-e063-6294a90a40461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78936-401-017893604010117 mg in 1 PATCH17 mgHistorical
78936-401-107893604011040 PATCH in 1 BOX (78936-401-10) / 17 mg in 1 PATCH (78936-401-01) 40 patch2024-04-19NoNoCurrent