FDA.reportPublic FDA data

Alba Botanica Acnedote Oil Control

Product NDC
61995-2062
11-digit product format
619952062
Labeler code
61995
Product ID
61995-2062_bfc790c0-64ff-4ccd-e053-2995a90a2ecc
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LOTION
Route
TOPICAL
Labeler
The Hain Celestial Group, Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-06
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61995-2062IInactivated by FDA2026-10-15
excluded packagepackage61995-206261995-2062-2IInactivated by FDA2026-10-15

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61995-2062-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61995-2062-2f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-2062-22025-07-29C16284748780-1ba0f9c33-2821-a910-e053-dadaa90a0b85AcneDote Oil Control Lotion
61995-2062-22021-02-05C16284748780-1ba0f9c33-2821-a910-e053-dadaa90a0b85AcneDote Oil Control Lotion
61995-2062-22021-01-29C16284748780-1ba0f9c33-2821-a910-e053-dadaa90a0b85AcneDote Oil Control Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-2062-2Alba Botanica Acnedote Oil Control57 g in 1 TUBELOTION577
61995-2062-2Alba Botanica Acnedote Oil Control1 in 1 CARTONLOTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-2062ALBA BOTANICA ACNEDOTE OIL CONTROL (SALICYLIC ACID) LOTION [THE HAIN CELESTIAL GROUP, INC.]7Legacy NDC, 2 package rows20241130_667715e3-b0b0-f6eb-e053-2a91aa0a29ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103568salicylic acid 2 % Topical LotionPSN667715e3-b0b0-f6eb-e053-2a91aa0a29ef7
103568salicylic acid 20 MG/ML Topical LotionSCD667715e3-b0b0-f6eb-e053-2a91aa0a29ef7
103568salicylic acid 2 % Topical LotionSY667715e3-b0b0-f6eb-e053-2a91aa0a29ef7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61995-2062-2619952062021 TUBE in 1 CARTON (61995-2062-2) > 57 g in 1 TUBE1 tube2015-08-060000-00-00NoNoCurrent