FDA.reportPublic FDA data

Topricin

Product NDC
61500-5547
Requested package NDC
61500-5547-0
11-digit product format
615005547
Labeler code
61500
Product ID
61500-5547_4044c51d-4d7d-881e-e063-6394a90a9927
Type
HUMAN OTC DRUG
Nonproprietary name
aesculus hippocastanum, arnica montana, belladonna, calendula officinalis, crotalus horridus, echinacea, graphites, heloderma horridum, lachesis mutus, naja tripudians, phosphorus, rhus toxicodendron, ruta graveolens, sulfur
Dosage form
CREAM
Route
TOPICAL
Labeler
Topical BioMedics, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-04-01
Substance
AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; PHOSPHORUS; RUTA GRAVEOLENS FLOWERING TOP; SULFUR; TOXICODENDRON PUBESCENS LEAF
Active strength
6; 6; 6; 4; 8; 4; 6; 8; 8; 8; 9; 6; 8; 8 [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61500-554761500-5547-0IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61500-554761500-5547-0IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61500-554761500-5547-0IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Additional Listing Data#

Finished product
Yes
Brand name base
Topricin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHOSPHORUS6 [hp_X]/227g
ARNICA MONTANA6 [hp_X]/227g
CROTALUS HORRIDUS HORRIDUS VENOM6 [hp_X]/227g
ECHINACEA ANGUSTIFOLIA4 [hp_X]/227g
GRAPHITE8 [hp_X]/227g
HELODERMA HORRIDUM VENOM4 [hp_X]/227g
LACHESIS MUTA VENOM6 [hp_X]/227g
NAJA NAJA VENOM8 [hp_X]/227g
RUTA GRAVEOLENS FLOWERING TOP8 [hp_X]/227g
AESCULUS HIPPOCASTANUM FLOWER8 [hp_X]/227g
ATROPA BELLADONNA9 [hp_X]/227g
TOXICODENDRON PUBESCENS LEAF6 [hp_X]/227g
CALENDULA OFFICINALIS FLOWERING TOP8 [hp_X]/227g
SULFUR8 [hp_X]/227g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27YLU75U4WInternal UNII lookup
O80TY208ZWInternal UNII lookup
YHA2XLJ956Internal UNII lookup
VB06AV5US8Internal UNII lookup
4QQN74LH4OInternal UNII lookup
O9M1UQ4YIOInternal UNII lookup
VSW71SS07IInternal UNII lookup
ZZ4AG7L7VMInternal UNII lookup
N94C2U587SInternal UNII lookup
KK0Z92II8MInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
6IO182RP7AInternal UNII lookup
18E7415PXQInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
321e83de-71e8-20b4-e054-00144ff8d46cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61500-5547-02023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-02023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-12023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-12023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-22023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-22023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-42023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-42023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-82023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-82023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-92023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-92023-01-06Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-02022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-02022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-12022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-12022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-22022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-22022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-42022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-42022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-82022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-82022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-92022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]
61500-5547-92022-01-28Topricin Foot Therapy Cream [2g, 0.75oz, 2oz, 4oz, 8oz, 16 oz]

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61500-5547-0Topricin2 g in 1 PACKETCREAM24
61500-5547-1Topricin21 g in 1 TUBECREAM214
61500-5547-2Topricin57 g in 1 TUBECREAM574
61500-5547-4Topricin113 g in 1 JARCREAM1134
61500-5547-8Topricin454 g in 1 BOTTLECREAM4544
61500-5547-9Topricin227 g in 1 BOTTLECREAM2274

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61500-5547TOPRICIN (AESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA HORRIDUM, LACHESIS MUTUS, NAJA TRIPUDIANS, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SULFUR) CREAM [TOPICAL BIOMEDICS, INC.]3Current NDC, Legacy NDC, 6 package rows20230107_321e83de-71e8-20b4-e054-00144ff8d46c.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
TopricinAESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLADONNA, CALENDULA OFFICINALIS, CROTALUS HORRIDUS, ECHINACEA, GRAPHITES, HELODERMA HORRIDUM, LACHESIS MUTUS, NAJA TRIPUDIANS, PHOSPHORUS, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SULFURTopical BioMedics, Inc.321e83de-71e8-20b4-e054-00144ff8d46c2025-10-03WarningsExact identifier
ndc (package): 61500-5547-0
ndc (product): 61500-5547
ndc11 (package): 61500554700

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61500-5547-0615005547002 g in 1 PACKET (61500-5547-0) 2 g2016-04-012026-04-01NoNoCurrent