Sarna

Product NDC
0316-0229
11-digit product format
003160229
Labeler code
0316
Product ID
0316-0229_ccfc6e1c-b9e0-326e-e053-2a95a90a09fb
Type
HUMAN OTC DRUG
Nonproprietary name
camphor and menthol
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-02-22
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM
Active strength
5 mg/mL; mg/mL
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 productproduct0316-0229DDiscontinued by firm2026-10-05
excluded packagepackage0316-02290316-0229-75DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-02-13Sarna Original
2023-02-13Sarna Original
2023-02-13Sarna Original
2023-01-30Sarna Original
2023-01-30Sarna Original
2023-01-30Sarna Original

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0229-75ML - Milliliter0316-022942e6b44a-3a46-4373-8962-e670088252f612019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0229SARNA (CAMPHOR AND MENTHOL) LOTION [CROWN LABORATORIES]20Legacy NDC20240929_7b2ff573-ca5a-d69a-e053-2a91aa0abcec.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0229-7500316022975222 mL in 1 BOTTLE, PUMP (0316-0229-75) 222 ml2018-12-010000-00-00NoNoCurrent