Home NDC 0316-0234 Sarna
Product NDC 0316-0234
11-digit product format 003160234
Labeler code 0316
Product ID 0316-0234_483436b1-9031-4992-e063-6394a90ad0c5
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine Hydrochloride, Menthol
Dosage form LOTION
Route TOPICAL
Labeler Crown Laboratories, Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-05
Substance MENTHOL; PRAMOXINE HYDROCHLORIDE
Active strength .5; 10 mg/1000mL; mg/1000mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sarna
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .5 mg/1000mL PRAMOXINE HYDROCHLORIDE 10 mg/1000mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0316-0234-12 Sarna 355 mL in 1 BOTTLE, PUMP LOTION 355 4 0316-0234-24 Sarna 5 mL in 1 PACKET LOTION 5 4 0316-0234-75 Sarna 222 mL in 1 BOTTLE, PUMP LOTION 222 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0316-0234 SARNA (PRAMOXINE HYDROCHLORIDE, MENTHOL) LOTION [CROWN LABORATORIES, INC] 2 Current NDC, 3 package rows 20250323_19c41e75-a654-90cf-e063-6394a90a7e97.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 49 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PAIN RELIEF PATCHES LIDOCAINE Harris Teeter 5a0501e8-bc06-4e33-8db8-93b21a715141 2025-12-29 Warnings Exact identifier application number: M017 Hot and Cold Medicated Patch MENTHOL Harris Teeter 9debd4ef-c21b-41ae-afd1-58f47c51c99c 2025-12-29 Warnings Exact identifier application number: M017 Maximum OTC Strength Feminine Anti-Itch Creme BENZOCAINE, RESORCINOL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) 0e9a711c-ddf4-af63-e063-6294a90a0ebe 2025-12-29 Warnings Exact identifier application number: M017 Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Harris Teeter 3f5b4eee-49c4-408c-9af2-e7924c26ac63 2025-12-29 Warnings Exact identifier application number: M017 talc-free medicated body MENTHOL Davion, Inc 27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b 2025-12-29 Warnings Exact identifier application number: M017 H-E-B Medicated Corn Starch Foot Powder MENTHOL Davion, Inc a6675e00-bc6b-4466-a283-4cece5f91970 2025-12-29 Warnings Exact identifier application number: M017 Maximum Strength Medicated Foot Powder MENTHOL Davion, Inc 7b442d99-ac19-4f65-828d-954c5350ef5a 2025-12-29 Warnings Exact identifier application number: M017 HEB Medicated Cornstarch Body Powder MENTHOL Davion, Inc df1331fb-48df-4f21-8564-0468078fd12d 2025-12-29 Warnings Exact identifier application number: M017 Honest Med Capsaicin Patch CAPSAICIN Proper Buys LLC 30169d44-b1b2-5c0f-e063-6294a90ae159 2025-12-28 Warnings Exact identifier application number: M017 Honest Med Lidocaine Lavender Roll-on LIDOCAINE HCL Proper Buys LLC 2dcd40a9-3fdd-a71e-e063-6294a90a704f 2025-12-28 Warnings Exact identifier application number: M017 Honest Med Lidocaine Pain Relief Patch LIDOCAINE Proper Buys LLC 13a5243f-7116-e4da-e063-6394a90aa543 2025-12-28 Warnings Exact identifier application number: M017 CVS Health Pain-Relieving Patch MENTHOL, METHYL SALICYLATE, CAMPHOR CVS Pharmacy, Inc. 1f90899c-eeca-2362-e063-6294a90aa0da 2025-12-28 Warnings Exact identifier application number: M017 CVS Health Cooling Patch MENTHOL CVS Pharmacy, Inc 1f90cefe-bcce-5e17-e063-6294a90a5736 2025-12-28 Warnings Exact identifier application number: M017 Point Relief LidoSpot with Menthol LIDOCAINE, MENTHOL Fabrication Enterprises f0c69693-bfea-4006-9620-63b222d25d38 2025-12-28 Warnings Exact identifier application number: M017 DISCOUNT DRUG MART PAIN RELIEF PATCHES LIDOCAINE Discount Drug Mart, Inc e36e7d0a-d554-4601-b535-b41ee84a6b24 2025-12-28 Warnings Exact identifier application number: M017 Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Discount Drug Mart, Inc c01e1a14-bfbc-4c52-8a67-b77acf2d8853 2025-12-28 Warnings Exact identifier application number: M017 TopCare Pain Relief Patch LIDOCAINE, MENTHOL Topco Associates LLC d4c89c4f-d69a-7786-e053-2995a90a71e7 2025-12-28 Warnings Exact identifier application number: M017 Kroger Lidocaine Pain Relieving LIDOCAINE HCL Kroger Company 12d94ba6-56ac-3816-e063-6394a90a44c6 2025-12-28 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Ahold U.S.A., Inc, 7e7a813e-424d-4a78-9c72-541c3c62606a 2025-12-28 Warnings Exact identifier application number: M017 Amazon Basics Cold and Hot Medicated Patch MENTHOL Amazon.com Services LLC e3b4db12-c846-b984-e053-2a95a90a8e9a 2025-12-28 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0316-0234-12 00316023412 355 mL in 1 BOTTLE, PUMP (0316-0234-12) 355 ml 2024-01-05 No No Current 0316-0234-24 00316023424 5 mL in 1 PACKET (0316-0234-24) 5 ml 2024-03-13 Yes No Current 0316-0234-75 00316023475 222 mL in 1 BOTTLE, PUMP (0316-0234-75) 222 ml 2024-01-05 No No Current