FDA.reportPublic FDA data

Calmara

Product NDC
67777-017
11-digit product format
677770017
Labeler code
67777
Product ID
67777-017_488e4308-742f-88af-e063-6394a90a7dda
Type
HUMAN OTC DRUG
Nonproprietary name
Calmara
Dosage form
LOTION
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-21
Substance
CAMPHOR (NATURAL)
Active strength
.5 mg/100mL
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
Calmara
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL).5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
487393e9-6619-6033-e063-6294a90a68b2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-017-01Calmara221.8 mL in 1 BOTTLE, PUMPLOTION221.82
67777-017-02Calmara24 in 1 CASELOTION242

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 90 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHINESE RED TIGER LIDOCAINE PATCHES4% LIDOCAINE, 1%MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36b9a7a2-5832-4ce5-e063-6294a90aed122025-06-12WarningsExact identifier
application number: M017
PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd375bc794-3289-e610-e063-6294a90a4f9b2025-06-12WarningsExact identifier
application number: M017
Methyl Salicylate 10% Pain RelievingMETHYL SALICYLATEPureTek Corporation376493eb-5142-db6d-e063-6294a90a1e732025-06-12WarningsExact identifier
application number: M017
Free and Pure Cold Therapy Pain ReliefMENTHOLWalgreen Co.22cbbffc-f876-411e-e063-6394a90a1b382025-06-12WarningsExact identifier
application number: M017
Methylten 25% Pain RelievingMETHYL SALICYLATEPureTek Corporation3767b97e-ab0c-ac26-e063-6394a90a00cf2025-06-12WarningsExact identifier
application number: M017
SPF 50 Mineral SunscreenZINC OXIDEInspec Solutions, LLC36af9a0a-536b-ee1a-e063-6394a90aace42025-06-11WarningsExact identifier
application number: M017
PLANTAR FASCIITIS Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd37570149-dae1-a4f2-e063-6294a90a32452025-06-11WarningsExact identifier
application number: M017
Diabecin CS CreamMENTHOL, CAPSAICINPuretek Corporation33ef2233-7a66-ee65-e063-6294a90ac55a2025-06-10WarningsExact identifier
application number: M017
KINKAN COOLDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLKINKANDO CO., LTD .82011efe-825c-4102-b6f1-59eff4c8040a2025-06-10WarningsExact identifier
application number: M017
MQUPIN Knee PatchKNEE PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.37438a70-dab7-ecb5-e063-6394a90afefb2025-06-10WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5% Roll OnMENTHOLLiquidCapsule Manufacturing LLC99424327-67e9-43b5-a117-94c9643413c12025-06-07WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLEbanel Laboratories, Inc36edbc3f-501c-c1ea-e063-6394a90af6af2025-06-06WarningsExact identifier
application number: M017
FREEZE IT Menthol Roll OnMENTHOLLiquidCapsule Manufacturing LLC33094afe-db9d-4b92-8047-6dd611484fc92025-06-05WarningsExact identifier
application number: M017
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd55e6b09-0587-61a9-e053-2995a90afaf52025-06-05WarningsExact identifier
application number: M017
FREEZE IT MentholMENTHOLLiquidCapsule Manufacturing LLCde8d8007-5718-4fb4-a8c6-4650d2ca9c8f2025-06-05WarningsExact identifier
application number: M017
HEEL PAIN Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36bacb5f-c1af-2e97-e063-6394a90afe5c2025-06-04WarningsExact identifier
application number: M017
Capsaicin 0.075% CreamCAPSAICINViolaCare, Inc.30911225-a6d7-4b2b-9005-b733373e28772025-06-04WarningsExact identifier
application number: M017
LidoGuardLIDOCAINE HCLViolaCare, Inc.531383aa-4f0f-4fe0-91f4-d809b39f160f2025-06-04WarningsExact identifier
application number: M017
HealthWise Lidocaine and MentholLIDOCAINE AND MENTHOLVeridian Healthcare36c27642-f913-1aad-e063-6294a90a43432025-06-04WarningsExact identifier
application number: M017
HealthWise Ultra OTC Strength Pain Relief CreamCAMPHOR, MENTHOL, AND METHYL SALICYLATEVeridian Healthcare36c3bbf9-a559-4c0d-e063-6394a90a8a1a2025-06-04WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-017-0167777001701221.8 mL in 1 BOTTLE, PUMP221.8 mlHistorical
67777-017-026777700170224 BOTTLE, PUMP in 1 CASE (67777-017-02) / 221.8 mL in 1 BOTTLE, PUMP (67777-017-01) 2026-01-21NoNoCurrent