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 75 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Feminine Anti-Itch Creme BENZOCAINE, RESORCINOL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) aa6cc963-dc60-5222-e053-2995a90acaf6 2025-10-06 Warnings Exact identifier application number: M017 TheraCare 2% Diphenhydramine Anti-Itch Cream DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Veridian Healthcare 5999b677-63dd-49c6-b5b8-7b3c117ecc5c 2025-10-06 Warnings Exact identifier application number: M017 HealthWise Pain Relief MENTHOL Veridian Healthcare 06be5331-7a1e-4ab3-9f17-2d350bd4b890 2025-10-02 Warnings Exact identifier application number: M017 equate Burn Relief LIDOCAINE HYDROCHLORIDE Walmart Inc a90cbd92-80a5-4463-8152-b83165121a6f 2025-10-02 Warnings Exact identifier application number: M017 AsperFlex HOT CAMPHOR, MENTHOL, METHYL SALICYLATE Akron Pharma Inc. a6cb0656-8866-44ff-b40c-73655ff68721 2025-10-02 Warnings Exact identifier application number: M017 AsperFlex Original Maximum Strength MENTHOL Akron Pharma Inc. d766c61e-c48b-4aff-97b0-678159479e03 2025-10-02 Warnings Exact identifier application number: M017 HealthWise Feminine Anti-Itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare 1f9110da-f448-8e20-e063-6294a90a4275 2025-10-02 Warnings Exact identifier application number: M017 PROSTAT FIRST AID Burn Ease, 0.9g LIDOCAINE ProStat First Aid LLC dc704403-e2aa-47f7-a7f4-f6afe1547ca8 2025-10-01 Warnings Exact identifier application number: M017 PROSTAT FIRST AID Burn Ease, 0.9g LIDOCAINE ProStat First Aid LLC e02558a9-fe2b-4f28-9fd3-7308f859d759 2025-10-01 Warnings Exact identifier application number: M017 FL Burn Ease, 0.9g LIDOCAINE ProStat First Aid LLC 4dc0d579-ab42-4ea5-9788-5e54d7d318a3 2025-10-01 Warnings Exact identifier application number: M017 Carmex Classic Lip Balm Medicated CAMPHOR (SYNTHETIC), WHITE PETROLATUM Carma Laboratories, Inc. c7a7626c-cf82-4301-af79-c5e85367e777 2025-10-01 Warnings Exact identifier application number: M017 Viaderma Calm Anti-Itch HYDROCORTISONE ViaDerma Distribution, Inc. 7afa2ccd-bfc6-48fc-9a14-a0c6d645844e 2025-10-01 Warnings Exact identifier application number: M017 AsperFlex Advance CAMPHOR, MENTHOL, METHYL SALICYLATE Akron Pharma Inc. d23d7f2b-4dcd-4c31-9d12-340f233018b4 2025-10-01 Warnings Exact identifier application number: M017 HEATING PAIN RELIEF METHYL SALICYLATE, MENTHOL SUNSET NOVELTIES, INC 4024d604-c8c7-2d73-e063-6294a90a2e80 2025-10-01 Warnings Exact identifier application number: M017 DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl oz MENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN) BH GLOBAL HOLDINGS LLC 1ddddbb6-2d01-c894-e063-6394a90acd58 2025-10-01 Warnings Exact identifier application number: M017 Tylenol Precise Pain Relieving Lidocaine 4% LIDOCAINE Kenvue Brands LLC 36a95afd-97e5-2271-e063-6394a90aea18 2025-09-30 Warnings Exact identifier application number: M017 Capsaicin Heat CAPSAICIN Universal Distribution Center LLC b3b40f77-3b0b-4111-968b-f3a87a5701fa 2025-09-29 Warnings Exact identifier application number: M017 Caring Mills Menthol 4% Roll-On MENTHOL Veridian Healthcare f4308c74-0860-4265-aeaf-a01301cca27a 2025-09-29 Warnings Exact identifier application number: M017 COLD AND HOT MEDICATED LARGE MENTHOL Universal Distribution Center LLC d6780230-aa96-4055-b054-be41358568b6 2025-09-29 Warnings Exact identifier application number: M017 COLD AND HOT MEDICATED MENTHOL Universal Distribution Center LLC c19aa620-401d-43c4-804c-3611cc39e9f2 2025-09-29 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