FDA.reportPublic FDA data

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
IngredientStrength
MENTHOL.5 mg/1000mL
PRAMOXINE HYDROCHLORIDE10 mg/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19c41e75-a654-90cf-e063-6394a90a7e97Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0234-12Sarna355 mL in 1 BOTTLE, PUMPLOTION3554
0316-0234-24Sarna5 mL in 1 PACKETLOTION54
0316-0234-75Sarna222 mL in 1 BOTTLE, PUMPLOTION2224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0234-75ML - Milliliter0316-0234f4af0a21-56e8-4d73-8123-a698e7314b4712024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0234SARNA (PRAMOXINE HYDROCHLORIDE, MENTHOL) LOTION [CROWN LABORATORIES, INC]2Current NDC, 3 package rows20250323_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 15 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and MentholLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC44840250-2112-6ef4-e063-6394a90acdcc2026-06-12WarningsExact identifier
application number: M017
DRAWYUM Pain Relief Gel-PatchLIDOCAINE 4% PAIN RELIEF GEL-PATCHJiangxi Yudexi Pharmaceutical Co., LTD497e6e18-ba46-0001-e063-6294a90af0262026-06-12WarningsExact identifier
application number: M017
NATUHEAL JOINT BACK PAIN RELIEFARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4c923afa-4d1e-0776-e063-6294a90a2f542026-06-12WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Aldermed Inc.4a7b532e-b292-b595-e063-6394a90acc9c2026-06-12WarningsExact identifier
application number: M017
MG PLUS MENTHOLMENTHOLRENU LABORATORIES, LLC53737365-b985-3800-e063-6294a90a37f22026-06-11WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc7c78d980-fc94-498c-aec5-464c0c76c8f42026-06-11WarningsExact identifier
application number: M017
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a47f1ed-d8cf-3b0b-e063-6394a90a932a2026-06-11WarningsExact identifier
application number: M017
Anti-Itch Soothing Wipes 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC81ab7fa7-d9b0-49dc-9782-02f37e588c5e2026-06-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Cream with LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcareef176d33-10b9-ddb2-e053-2995a90a76e32026-06-10WarningsExact identifier
application number: M017
Warm Patch Tong Gu Huo Luo GaoPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory6906c4a0-1557-45e3-b915-80e4dd652ee72026-06-10WarningsExact identifier
application number: M017
LidoMedixLIDOCAINE, MENTHOL, CAMPHORAbsolute Therapeutics, LLC53d504ef-eea3-6a47-e063-6394a90a1f652026-06-09WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsExact identifier
application number: M017
Terramed Just Think Comfort GynoCare BV Guard Intimate WashPRAMOXINE HYDROCHLORIDERida LLC09964550-049c-4c3b-817d-37e660c2e45c2026-06-08WarningsExact identifier
application number: M017
Quality Choice Lidocaine Pain Relief PatchLIDOCAINEQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)526abe69-4bbc-6e73-e063-6394a90ad25d2026-06-08WarningsExact identifier
application number: M017
Dcsily Numbing CreamLIDOCAINEShenzhen Xinxin Yunhai Technology Co., Ltd.53cab09c-6d5d-471e-e063-6294a90aa9772026-06-08WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin cream for sensitive skinCAPSAICIN 0.1%Easment LLC537e0106-9e1c-66b8-e063-6294a90ac5382026-06-05WarningsExact identifier
application number: M017
Maximum Strength Pain ReliefMENTHOL CREAMOWELL NATURALS LLC5388f2c5-8cfd-a601-e063-6294a90a2e5f2026-06-04WarningsExact identifier
application number: M017
MG PLUS ROLL ONMENTHOL ROLL ONRENU LABORATORIES, LLC535dc42f-38c7-2afc-e063-6294a90ae23d2026-06-03WarningsExact identifier
application number: M017
OP First Aid Series Insect Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.b43af183-834a-0f64-e053-2995a90a32182026-06-03WarningsExact identifier
application number: M017
PURE PRIMAL DELAYLIDOCAINE HCLProdigy Media Inc1ddab664-7c44-452f-854f-e386cd69505e2026-06-03WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0316-0234-1200316023412355 mL in 1 BOTTLE, PUMP (0316-0234-12) 355 ml2024-01-05NoNoCurrent
0316-0234-24003160234245 mL in 1 PACKET (0316-0234-24) 5 ml2024-03-13YesNoCurrent
0316-0234-7500316023475222 mL in 1 BOTTLE, PUMP (0316-0234-75) 222 ml2024-01-05NoNoCurrent