Dragon Pain Relieving Balm

Product NDC
83552-121
11-digit product format
835520121
Labeler code
83552
Product ID
83552-121_4369e616-f422-3001-e063-6394a90a8e53
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, menthol
Dosage form
SALVE
Route
TOPICAL
Labeler
Americanna Wellness, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-04
Substance
CAMPHOR (NATURAL); MENTHOL
Active strength
11; 15 g/100g; 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
Dragon Pain Relieving Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)11 g/100g
MENTHOL15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
154d8821-3e76-b0e2-e063-6294a90ae077Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83552-121-00Dragon Pain Relieving Balm1 in 1 CARTONSALVE12
83552-121-00Dragon Pain Relieving Balm96.4 g in 1 CONTAINERSALVE96.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83552-121DRAGON PAIN RELIEVING BALM (CAMPHOR, MENTHOL) SALVE [AMERICANNA WELLNESS, INC.]1Current NDC, 2 package rows20240406_154d8821-3e76-b0e2-e063-6294a90ae077.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 115 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Serum XLIDOCAINE HYDROCHLORIDEAO Biologix, LLCe07b6268-6400-6849-e053-2a95a90a8b3e2024-12-11WarningsExact identifier
application number: M017
PlusCBD Pain Cream (Penetrating) 2ozCAMPHOR, MENTHOLCV Sciences, Inc.ca39d327-6bf3-3408-e053-2a95a90af2d52024-12-11WarningsExact identifier
application number: M017
Blistex MedicatedDIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOLBlistex Inc.e95439d3-f12b-4c1c-999a-79f2ddba4cfb2024-12-11WarningsExact identifier
application number: M017
Blistex Foille Medicated First AidBENZOCAINE AND CHLOROXYLENOLBlistex Inc.e2eca808-e97b-43e0-aa51-7025cc61c7a82024-12-11WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEJ&A Digital Inc.ff95a536-35b3-4006-b43c-cce359e86aa92024-12-10WarningsExact identifier
application number: M017
TheraCare Maximum Strength Pain Relief PatchLIDOCAINEVeridian Healthcaredfaf8a77-2276-4791-e053-2a95a90a32882024-12-10WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEAlexso, Inceef555d3-f23d-4847-93f3-fa7a06072a0f2024-12-09WarningsExact identifier
application number: M017
Lidocaine 4 PercentLIDOCAINESA3, LLC651710db-3c50-4bcf-b7cc-9ed24f6634272024-12-09WarningsExact identifier
application number: M017
HealthWise Pain Relief Lidocaine PatchLIDOCAINE 4%Veridian Healthcare28db1c03-d01f-83ea-e063-6294a90aee262024-12-09WarningsExact identifier
application number: M017
Joint and Muscle Pain ReliefMENTHOLAllure Labse82f99fd-c2ef-686f-e053-2a95a90a1dc92024-12-09WarningsExact identifier
application number: M017
Tough Love Pain RelievingLIDOCAINE HCLAllure Labsee8c1a2b-36ef-6fd7-e053-2a95a90a9c012024-12-09WarningsExact identifier
application number: M017
CapsaicinCAPSAICINSA3, LLC5617e91d-e650-4a0d-8565-b8288ea41c772024-12-09WarningsExact identifier
application number: M017
Medicaine Sting and BiteBENZOCAINEJames Alexander Corporation753e6cbe-31e0-4017-93d0-8b4bf5972f372024-12-09WarningsExact identifier
application number: M017
AUVON Pain Relief Roll-onMENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.df239c4d-af6a-41ca-baed-d0788782ce9f2024-12-08WarningsExact identifier
application number: M017
AUVON Pain Relief Roll-onLIDOCAINESHENZHEN YUWEN E-COMMERCE CO., LTD.8b30f623-6077-4f2e-8fa4-ce4a298953b52024-12-08WarningsExact identifier
application number: M017
QC Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLChain Drug Marketing Associationb5e41e3a-81df-3a63-e053-2a95a90a58392024-12-08WarningsExact identifier
application number: M017
QC Lidocaine Maximum StrengthLIDOCAINE HCLChain Drug Marketing Associationb5e1b1ab-8a95-2d2d-e053-2995a90aea532024-12-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAlexso, Inc433da27d-04fb-481a-bbb0-874bb72c806a2024-12-06WarningsExact identifier
application number: M017
POMG PAIN RELIEF BODYLIDOCAINEPOMG LLC28d7ac46-b27f-43bb-e063-6294a90a93ed2024-12-06WarningsExact identifier
application number: M017
Capsaicin 0.1 PercentCAPSAICINAlexso, Inc0090ca38-6433-45c4-9453-edf2788c14c62024-12-06WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83552-121-00835520121001 CONTAINER in 1 CARTON (83552-121-00) / 96.4 g in 1 CONTAINER1 container2024-04-04NoNoCurrent