ACNE SOLUTIONS

Product NDC
49527-825
11-digit product format
495270825
Labeler code
49527
Product ID
49527-825_4bbc494e-e1c7-7800-e063-6294a90a9f64
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
2008-12-01
Marketing end
2027-04-19
Substance
SALICYLIC ACID
Active strength
10 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACNE SOLUTIONS
Brand name suffix
SPOT HEALING ACNE MEDICATION

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui251380

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-825-012021-04-13C16284748780-19d75b9d0-dac8-f424-e053-dadaa90a57ceACNE SOLUTIONS SPOT HEALING ACNE MEDICATION
49527-825-012020-01-31C16284748780-19d75b9d0-dac8-f424-e053-dadaa90a57ceACNE SOLUTIONS SPOT HEALING ACNE MEDICATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-825-01ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION15 mL in 1 TUBEGEL1511
49527-825-01ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION1 in 1 CARTONGEL111
49527-825-02ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION1 in 1 CARTONGEL111
49527-825-02ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION30 mL in 1 BOTTLEGEL3011
49527-825-03ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION1 in 1 CARTONGEL111
49527-825-03ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION3 mL in 1 TUBEGEL311
49527-825-04ACNE SOLUTIONSSPOT HEALING ACNE MEDICATION1.5 mL in 1 PACKETGEL1.511

DailyMed Socrata Ingredients#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251380salicylic acid 1 % Topical GelPSNc09ee4f6-b8f9-4d20-982a-fb490830bd3411
251380salicylic acid 0.01 MG/MG Topical GelSCDc09ee4f6-b8f9-4d20-982a-fb490830bd3411
251380salicylic acid 1 % Topical GelSYc09ee4f6-b8f9-4d20-982a-fb490830bd3411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-825-01495270825011 TUBE in 1 CARTON (49527-825-01) > 15 mL in 1 TUBE1 tube2022-04-280000-00-00NoNoCurrent
49527-825-02495270825021 BOTTLE in 1 CARTON (49527-825-02) > 30 mL in 1 BOTTLE1 bottle2022-04-280000-00-00NoNoCurrent
49527-825-03495270825031 TUBE in 1 CARTON (49527-825-03) > 3 mL in 1 TUBE1 tube2022-04-280000-00-00NoNoCurrent
49527-825-04495270825041.5 mL in 1 PACKET (49527-825-04) 1.5 ml2022-06-020000-00-00YesNoCurrent