Dragon Pain Relieving Balm

Product NDC
83552-105
11-digit product format
835520105
Labeler code
83552
Product ID
83552-105_445dd496-f683-9383-e063-6394a90ac864
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
SALVE
Route
TOPICAL
Labeler
Americanna Wellness, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-10
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
3.1; 5.3 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 (SYNTHETIC)3.1 g/100g
MENTHOL5.3 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83552-105-002025-11-24C16284748780-12cef2736-834d-d83d-e063-dadaa90ab31fRegular Strength Isolate 3.4 oz
83552-105-002025-01-30C16284748780-12cef2736-834d-d83d-e063-dadaa90ab31fRegular Strength Isolate 3.4 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83552-105-00Dragon Pain Relieving Balm1 in 1 CARTONSALVE12
83552-105-00Dragon Pain Relieving Balm96.4 g in 1 CONTAINERSALVE96.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83552-105DRAGON PAIN RELIEVING BALM (CAMPHOR, MENTHOL) SALVE [AMERICANNA WELLNESS, INC.]1Current NDC, 2 package rows20230712_002db658-6b1f-ea49-e063-6294a90ae3e7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83552-105-00835520105001 CONTAINER in 1 CARTON (83552-105-00) / 96.4 g in 1 CONTAINER1 container2023-07-10NoNoCurrent