Dragon Pain Relieving Balm

Product NDC
83552-115
11-digit product format
835520115
Labeler code
83552
Product ID
83552-115_445dbfa0-5454-e1d8-e063-6394a90a43be
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
2023-12-21
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
10; 11 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)10 g/100g
MENTHOL11 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83552-115-002025-11-24C16284748780-12cef2736-a674-d83d-e063-dadaa90ab31fDragon Pain Relieving Balm 3.4oz (XS BS)
83552-115-002025-01-30C16284748780-12cef2736-a674-d83d-e063-dadaa90ab31fDragon Pain Relieving Balm 3.4oz (XS BS)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83552-115-00Dragon Pain Relieving Balm1 in 1 CARTONSALVE12
83552-115-00Dragon Pain Relieving Balm96.4 g in 1 CONTAINERSALVE96.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83552-115DRAGON PAIN RELIEVING BALM (CAMPHOR, MENTHOL) SALVE [AMERICANNA WELLNESS, INC.]1Current NDC, 2 package rows20231222_0d129641-eaea-c3ee-e063-6394a90aa58f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83552-115-00835520115001 CONTAINER in 1 CARTON (83552-115-00) / 96.4 g in 1 CONTAINER1 container2023-12-21NoNoCurrent