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 42 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cortizone 10 Fast Acting Itch Relief CoolingHYDROCORTISONEChattem, Inc.01cd77e3-380f-4487-ae6e-3ac45355d8a42026-01-14WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd0174411c-1b10-4298-b820-87b24065b1182026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing for EczemaHYDROCORTISONEChattem, Inc.31dc0f1f-ddd8-41dc-b669-b24655634d552026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Overnight CremeHYDROCORTISONEChattem, Inc.ef2eda7e-d6a8-47e3-9d80-6074af6773dc2026-01-14WarningsExact identifier
application number: M017
CVS Pain Relief Lavender ScentMENTHOL 4%CVS484b0833-9f8a-f155-e063-6294a90a18692026-01-13WarningsExact identifier
application number: M017
EARTHS CARE ANTI-ITCHCAMPHOR (NATURAL), MENTHOLDLC Laboratories, Inc.d1eabb5f-7086-4ff0-a398-3703c9ecd4412026-01-13WarningsExact identifier
application number: M017
HealthWise Cold Therapy Menthol Pain ReliefMENTHOLVeridian Healthcare25e3d9cd-6ba3-4e06-8853-324b9d6692482026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.1ac2ed54-194c-4de2-8e7f-6e74ca32aa402026-01-13WarningsExact identifier
application number: M017
Pain Release Joint and Arthritis CreamMENTHOLSaje Natural Business Inc.18b24d75-17f7-1a35-e063-6394a90a55e02026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.a32b0950-3467-4e37-988d-104836af59712026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.92eec6e7-0367-43c6-bd28-1762390a71142026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.481a493b-0620-46ac-8228-e9964b7eb24b2026-01-13WarningsExact identifier
application number: M017
RestoralMENTHOLSaje Natural Business Inc.5b6176c1-9ed9-1950-e053-2a91aa0a434e2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Eucalyptus Essential OilLIDOCAINE HCLChattem, Inc.03e247b4-a2e2-4354-a018-880f1bc987fd2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine Foot (Diabetic)LIDOCAINE HYDROCHLORIDEChattem, Inc.2c33d15e-5032-46d9-bd98-5abc7df3bbe52026-01-13WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Essential Oils Rosemary MintLIDOCAINEChattem, Inc.9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab2026-01-13WarningsExact identifier
application number: M017
Capzasin HP Arthritis Pain ReliefCAPSAICINChattem, Inc.345c9159-0efe-436b-9068-3b717678936b2026-01-13WarningsExact identifier
application number: M017
Capzasin Quick ReliefCAPSAICIN AND MENTHOLChattem, Inc.d6c313a3-8dc6-4231-95b6-ac9399e1c1be2026-01-13WarningsExact identifier
application number: M017
Aspercreme Pain RelievingTROLAMINE SALICYLATEChattem, Inc.97dd587b-ecc3-4b4b-a116-6355d3c6ea6d2026-01-13WarningsExact identifier
application number: M017
Dr Wellskin Numbing Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD482f25cc-dee3-c3b6-e063-6294a90a86742026-01-12WarningsExact 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