Terrasil Balanitis Relief

Product NDC
24909-119
Requested package NDC
24909-119-14
11-digit product format
249090119
Labeler code
24909
Product ID
24909-119_2763f0a0-abfe-19d4-e063-6394a90a1a7e
Type
HUMAN OTC DRUG
Nonproprietary name
Sulfur, Symphytum Officinale (Comfrey)
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-06-10
Substance
SULFUR; SYMPHYTUM OFFICINALE WHOLE
Active strength
1; 1 [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage24909-11924909-119-14DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Terrasil Balanitis Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR1 [hp_X]/g
SYMPHYTUM OFFICINALE WHOLE1 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup
H8FJJ6KX5YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16c243e0-dec4-4643-949f-48dfd6bc5c08Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24909-119-14Terrasil Balanitis Relief14 g in 1 JAROINTMENT144
24909-119-15Terrasil Balanitis Relief14 g in 1 TUBEOINTMENT144
24909-119-28Terrasil Balanitis Relief28 g in 1 TUBEOINTMENT284
24909-119-44Terrasil Balanitis Relief44 g in 1 JAROINTMENT444
24909-119-50Terrasil Balanitis Relief50 g in 1 TUBEOINTMENT504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU70TERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
SYMPHYTUM OFFICINALE WHOLEACTIVE INGREDIENTH8FJJ6KX5YTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
SULFURACTIVE MOIETY70FD1KFU70TERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
SYMPHYTUM OFFICINALE WHOLEACTIVE MOIETYH8FJJ6KX5YTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
ALLANTOININACTIVE INGREDIENT344S277G0ZTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
CEDRUS ATLANTICA BARK OILINACTIVE INGREDIENTZX5QRE4U60TERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8TERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
SILVER OXIDEINACTIVE INGREDIENT897WUN6G6TTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZTERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24909-119TERRASIL BALANITIS RELIEF (SULFUR, SYMPHYTUM OFFICINALE (COMFREY)) OINTMENT [AIDANCE SCIENTIFIC, INC., DBA AIDANCE SKINCARE & TOPICAL SOLUTIONS]4Current NDC, Legacy NDC, 5 package rows20241123_16c243e0-dec4-4643-949f-48dfd6bc5c08.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terrasil Balanitis ReliefSULFUR, SYMPHYTUM OFFICINALE (COMFREY)Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions16c243e0-dec4-4643-949f-48dfd6bc5c082024-11-20WarningsExact identifier
ndc (package): 24909-119-14
ndc (product): 24909-119
ndc11 (package): 24909011914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24909-119-142490901191414 g in 1 JAR (24909-119-14) 14 g2014-06-100000-00-00NoNoCurrent