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 77 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ink Scribd Numbing LIDOCAINE HCL Prodigy Media Inc 54173858-aff0-43b2-bc7b-c4ecab9bc3e5 2025-09-17 Warnings Exact identifier application number: M017 Inkorporated Numbing LIDOCAINE HCL Prodigy Media Inc 3017056c-f3c6-4300-8344-bf6e7d32e870 2025-09-17 Warnings Exact identifier application number: M017 TattooGirl Numbing LIDOCAINE HCL Prodigy Media Inc 6abe4540-f6c9-412a-83f3-682df7715057 2025-09-17 Warnings Exact identifier application number: M017 Dr Tatty Numbing LIDOCAINE HCL Prodigy Media Inc 5bb558c1-bf8f-4956-8732-e19720f62f31 2025-09-17 Warnings Exact identifier application number: M017 Burn Ease Cooling LIDOCAINE ProStat First Aid LLC ec201ca1-efa0-4797-aec3-115647c29abd 2025-09-17 Warnings Exact identifier application number: M017 MedFreeze Naturally Cool Pain Relief MENTHOL MEDKO LLC 240f2346-c585-4334-997c-45db6268d7c4 2025-09-15 Warnings Exact identifier application number: M017 MEDISTIK DUAL HOT AND COLD METHYL SALICYLATE, MENTHOL Natureteq Inc. ba5f4626-f077-4a28-8dcc-dacd50741ead 2025-09-15 Warnings Exact identifier application number: M017 MEDISTIK ICE MENTHOL, CAMPHOR Natureteq Inc. c1077744-7b9a-4536-8faf-e21994a43ea5 2025-09-15 Warnings Exact identifier application number: M017 Caring Mills Vaginal Anti-Itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare cd379e74-2841-47e4-b95a-de1b341b397f 2025-09-15 Warnings Exact identifier application number: M017 Lidocaine-Pain-Relief-Patch LIDOCAINE-PAIN-RELIEF-PATCH Henan Enokon Medical Instrument Co., Ltd. 3ecfa867-50f6-d98a-e063-6394a90aefa0 2025-09-14 Warnings Exact identifier application number: M017 Meijer Hydrocortsione Cream HYDROCORTSIONE CREAM 1% Meijer Distribution Inc. 1cbddb7e-f2e3-0951-e063-6394a90a3d37 2025-09-12 Warnings Exact identifier application number: M017 JO Prolonger with Benzocaine BENZOCAINE CC Wellness LLC d955f612-1267-f1be-e053-2995a90a5345 2025-09-12 Warnings Exact identifier application number: M017 JO for Him Prolonger with Lidocaine LIDOCAINE CC Wellness LLC b12dc6a3-142d-3219-e053-2995a90aead0 2025-09-12 Warnings Exact identifier application number: M017 Walgreens Medicated Foot Powder MENTHOL Davion, Inc 58e1e7f7-6284-411f-9765-0e63eabca0f3 2025-09-12 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Amerisource Bergen 614f1e56-891f-4620-be10-0c075a1dbc3f 2025-09-11 Warnings Exact identifier application number: M017 Industrial Itch and Pain Relief DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE R & R Lotion, Inc 236415fc-f923-4a82-b54a-ecaf666dd2e0 2025-09-11 Warnings Exact identifier application number: M017 Eco Lips Menthol Medicated Lip Balm MENTHOL Eco Lips, Inc. fc4c25d6-6109-dfd8-e053-6394a90a4e91 2025-09-10 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE 1% Encube Ethicals, Inc. d6f5c0df-6262-4704-bb24-430f66bb2ca8 2025-09-09 Warnings Exact identifier application number: M017 Blue-Emu Lidocaine Pain Relief Cream LIDOCAINE CREAM 4% Kingsway Pharmaceuticals dba NFI, LLC 592811f2-e21c-6a58-e053-2991aa0a69a9 2025-09-09 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Unifirst First Aid Corporation 282ed5ef-8c2a-4092-9d99-1a7eee7a39e3 2025-09-09 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