ACNE SOLUTIONS

Product NDC
49527-117
11-digit product format
495270117
Labeler code
49527
Product ID
49527-117_3c6a2131-7bad-45ce-e063-6394a90a5eb9
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-21
Substance
BENZOYL PEROXIDE
Active strength
25 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACNE SOLUTIONS
Brand name suffix
ALL-OVER CLEARING TREATMENT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui200009

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-117-01ACNE SOLUTIONSALL-OVER CLEARING TREATMENT50 mL in 1 TUBELOTION503
49527-117-01ACNE SOLUTIONSALL-OVER CLEARING TREATMENT1 in 1 CARTONLOTION13
49527-117-02ACNE SOLUTIONSALL-OVER CLEARING TREATMENT1 in 1 CARTONLOTION13
49527-117-02ACNE SOLUTIONSALL-OVER CLEARING TREATMENT30 mL in 1 TUBELOTION303
49527-117-03ACNE SOLUTIONSALL-OVER CLEARING TREATMENT15 mL in 1 TUBELOTION153
49527-117-03ACNE SOLUTIONSALL-OVER CLEARING TREATMENT1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-117ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT (BENZOYL PEROXIDE) LOTION [CLINIQUE LABORATORIES LLC]2Current NDC, 6 package rows20240723_0d0cfec0-5d18-c347-e063-6394a90a912c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200009benzoyl peroxide 2.5 % Topical LotionPSN0d0cfec0-5d18-c347-e063-6394a90a912c3
200009benzoyl peroxide 25 MG/ML Topical LotionSCD0d0cfec0-5d18-c347-e063-6394a90a912c3
200009benzoyl peroxide 2.5 % Topical LotionSY0d0cfec0-5d18-c347-e063-6394a90a912c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49527-117-01495270117011 TUBE in 1 CARTON (49527-117-01) / 50 mL in 1 TUBE1 tube2023-12-21NoNoHistorical
49527-117-02495270117021 TUBE in 1 CARTON (49527-117-02) / 30 mL in 1 TUBE1 tube2023-12-21NoNoHistorical
49527-117-03495270117031 TUBE in 1 CARTON (49527-117-03) / 15 mL in 1 TUBE1 tube2023-12-21NoNoHistorical