PRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC

Product NDC
64657-003
11-digit product format
646570003
Labeler code
64657
Product ID
64657-003_d38cf8be-3b54-4519-9768-16f535dceae5
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Naturopathica Holistic Health
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-10-25
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 g/100mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64657-003IInactivated by FDA2026-10-20
excluded packagepackage64657-00364657-003-01IInactivated by FDA2026-10-20
excluded packagepackage64657-00364657-003-03IInactivated by FDA2026-10-20

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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64657-003-018af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64657-003-038af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64657-003-01834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64657-003-03834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64657-003-011332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64657-003-031332a3947898…d4bfe170f9cd…

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
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64657-003-01PRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC150 mL in 1 BOTTLE, PUMPLIQUID1502
64657-003-01PRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC1 in 1 CARTONLIQUID12
64657-003-03PRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC150 mL in 1 BOTTLE, GLASSLIQUID1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64657-003PRICKLY PEAR AND SALICYLIC ACID ACNE CLEARING TONIC (SALICYLIC ACID) LIQUID [NATUROPATHICA HOLISTIC HEALTH]2Legacy NDC, 3 package rows20240601_9345456f-a16b-47fd-a1a5-7d4b0bcc1c7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251577salicylic acid 2 % Topical SolutionPSN9345456f-a16b-47fd-a1a5-7d4b0bcc1c7f2
251577salicylic acid 20 MG/ML Topical SolutionSCD9345456f-a16b-47fd-a1a5-7d4b0bcc1c7f2
251577salicylic acid 2 % Topical SolutionSY9345456f-a16b-47fd-a1a5-7d4b0bcc1c7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64657-003-01646570003011 BOTTLE, PUMP in 1 CARTON (64657-003-01) > 150 mL in 1 BOTTLE, PUMP2021-10-250000-00-00NoNoCurrent
64657-003-0364657000303150 mL in 1 BOTTLE, GLASS (64657-003-03) 150 ml2021-10-250000-00-00NoNoCurrent