FDA.reportPublic FDA data

Cetilar

Product NDC
84797-000
11-digit product format
847970000
Labeler code
84797
Product ID
84797-000_2dd14e68-9b33-bad8-e063-6394a90a9fc1
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 1.4%
Dosage form
CREAM
Route
TOPICAL
Labeler
PharmaNutra Usa Corp.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
Substance
MENTHOL
Active strength
1.4 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Cetilar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2391332Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2dd14bd4-b4e1-bc7d-e063-6394a90a1e59Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84797-000-49Cetilar49 g in 1 TUBECREAM491
84797-000-49Cetilar1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84797-000CETILAR (MENTHOL 1.4%) CREAM [PHARMANUTRA USA CORP.]1Current NDC, 2 package rows20250213_2dd14bd4-b4e1-bc7d-e063-6394a90a1e59.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 53 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ResinolPETROLATUM AND RESORCINOLResiCal, Inc.03f57a4a-f94b-4ba6-b709-41cfb6e162612025-12-17WarningsExact identifier
application number: M017
HealthWise Maximum Pain ReliefLIDOCAINEVeridian Healthcareafc3c16d-0076-44b2-ae7e-5f36d4d8088e2025-12-17WarningsExact identifier
application number: M017
HealthWise Max Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcaref39a27da-6799-4fc6-97ca-101eac4a93602025-12-17WarningsExact identifier
application number: M017
HealthWise Original MentholMENTHOLVeridian Healthcaree4bfb6b0-545e-4fbc-8538-4f41a6be10252025-12-17WarningsExact identifier
application number: M017
Welly Polka First Aid KitHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEDongguan Shenglian Tins Products Co., Ltd.d7c4314c-c4c6-4adf-b384-3ac7a71083192025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain TherapyMENTHOLWise Consumer Products2410a199-f4a3-da6c-e063-6394a90aaace2025-12-17WarningsExact identifier
application number: M017
LidocaineLIDOCAINE, MENTHOLVive Health LLC462d3b24-643e-91da-e063-6394a90a0e1d2025-12-17WarningsExact identifier
application number: M017
Teevodar Pain RelievingMENTHOLSod-e Biotech Ltd205b0fef-4f00-db2e-e063-6294a90a93b82025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain ReliefMENTHOLWISE CONSUMER PRODUCTS CO.116045df-891b-f370-e063-6294a90abe422025-12-17WarningsExact identifier
application number: M017
Frankincense and Myrrh Intensive Foot TherapyMENTHOLWise Consumer Products23e56c6b-0f2b-721f-e063-6394a90a1ed02025-12-17WarningsExact identifier
application number: M017
Tiger Balm Ultra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f0561804-e0f7-495d-9768-9b86a208c51e2025-12-17WarningsExact identifier
application number: M017
Kwan LoongMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.54bcb26e-786a-403e-9330-11ae9e3c013a2025-12-17WarningsExact identifier
application number: M017
Magsoothium Body Cooling FormulaMENTHOLUbu/Elements, Inc.f7fb6ac9-a920-a440-e053-6394a90aaa352025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD Body LavenderMENTHOLUbu/Elements, Inc.f9b87fbe-b889-67a1-e053-6394a90acbcd2025-12-16WarningsExact identifier
application number: M017
Aquaphor Itch ReliefHYDROCORTISONEBeiersdorf Incb1d0333f-ba60-35d8-e053-2995a90af9322025-12-16WarningsExact identifier
application number: M017
Magsoothium CBD BodyMENTHOLUbu/Elements, Inc.00b2ef34-42d7-523c-e063-6294a90a753d2025-12-16WarningsExact identifier
application number: M017
GENTLECARE HAND AND SKIN SANITIZERBENZALKONIUM CHLORIDEPARAGON SOLUTIONS US, INC.16650277-fa62-485e-9a82-7763d2b501682025-12-16WarningsExact identifier
application number: M017
Welly First Aid Kit RefillHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEDongguan Shenglian Tins Products Co., Ltd.4bc93855-4009-4b49-9fb4-e5864054153d2025-12-16WarningsExact identifier
application number: M017
LidocainePain pain reliving gel-patchPAIN RELIVING GEL-PATCHShenzhen Yuetai Electronic Commerce Co., Ltd461ebbdd-0f26-a333-e063-6394a90a7a3e2025-12-16WarningsExact identifier
application number: M017
ZestamaCAPSAICINV2 Pharma LLCc9b46759-b8df-4ff4-815e-8e032c2635c02025-12-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2391332menthol 1.4 % Topical CreamPSN2dd14bd4-b4e1-bc7d-e063-6394a90a1e591
2391332menthol 14 MG/ML Topical CreamSCD2dd14bd4-b4e1-bc7d-e063-6394a90a1e591
2391332menthol 1.4 % Topical CreamSY2dd14bd4-b4e1-bc7d-e063-6394a90a1e591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84797-000-49847970000491 TUBE in 1 CARTON (84797-000-49) / 49 g in 1 TUBE1 tube2025-02-01NoNoCurrent