ACNE SOLUTIONS

Product NDC
49527-116
11-digit product format
495270116
Labeler code
49527
Product ID
49527-116_4bbc9411-33cb-c754-e063-6394a90ae093
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-21
Substance
SALICYLIC ACID
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACNE SOLUTIONS
Brand name suffix
CLINICAL CLEARING gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui251380

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-116-01ACNE SOLUTIONSCLINICAL CLEARING gel1 in 1 CARTONGEL13
49527-116-01ACNE SOLUTIONSCLINICAL CLEARING gel30 mL in 1 BOTTLEGEL303
49527-116-02ACNE SOLUTIONSCLINICAL CLEARING gel1 in 1 CARTONGEL13
49527-116-02ACNE SOLUTIONSCLINICAL CLEARING gel15 mL in 1 BOTTLEGEL153
49527-116-03ACNE SOLUTIONSCLINICAL CLEARING gel3 mL in 1 TUBEGEL33
49527-116-03ACNE SOLUTIONSCLINICAL CLEARING gel1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-116ACNE SOLUTIONS CLINICAL CLEARING GEL (SALICYLIC ACID) GEL [CLINIQUE LABORATORIES LLC]2Current NDC, 6 package rows20241226_0d0c763b-d9aa-c342-e063-6294a90a6e79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251380salicylic acid 1 % Topical GelPSN0d0c763b-d9aa-c342-e063-6294a90a6e793
251380salicylic acid 0.01 MG/MG Topical GelSCD0d0c763b-d9aa-c342-e063-6294a90a6e793
251380salicylic acid 1 % Topical GelSY0d0c763b-d9aa-c342-e063-6294a90a6e793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49527-116-01495270116011 BOTTLE in 1 CARTON (49527-116-01) / 30 mL in 1 BOTTLE1 bottle2023-12-21NoNoHistorical
49527-116-02495270116021 BOTTLE in 1 CARTON (49527-116-02) / 15 mL in 1 BOTTLE1 bottle2023-12-21NoNoHistorical
49527-116-03495270116031 TUBE in 1 CARTON (49527-116-03) / 3 mL in 1 TUBE1 tube2023-12-21NoNoHistorical