FDA.reportPublic FDA data

Prid

Product NDC
54973-4099
Requested package NDC
54973-4099-2
11-digit product format
549734099
Labeler code
54973
Product ID
54973-4099_50146c92-51c7-846c-e063-6294a90a6760
Type
HUMAN OTC DRUG
Nonproprietary name
Ichthammol, Calcium Sulfide, Calendula Officinalis Flowering Top, Arnica Montana, Echinacea Angustifolia, Silicon Dioxide, Sulfur
Dosage form
SALVE
Route
TOPICAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-03-01
Substance
ARNICA MONTANA; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA ANGUSTIFOLIA; ICHTHAMMOL; SILICON DIOXIDE; SULFUR
Active strength
3; 12; 3; 3; 2; 12; 12 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM SULFIDE3 [hp_X]/g
SILICON DIOXIDE12 [hp_X]/g
ECHINACEA ANGUSTIFOLIA3 [hp_X]/g
ARNICA MONTANA3 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP2 [hp_X]/g
ICHTHAMMOL12 [hp_X]/g
SULFUR12 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1MBW07J51QInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
VB06AV5US8Internal UNII lookup
O80TY208ZWInternal UNII lookup
18E7415PXQInternal UNII lookup
NQ14646378Internal 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
49689eeb-7790-07f1-e063-6294a90a2df2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4099-1Prid1 in 1 CARTONSALVE12
54973-4099-1Prid18 g in 1 CANSALVE182
54973-4099-2Prid18 g in 1 CANSALVE182
54973-4099-2Prid1 in 1 CARTONSALVE12

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
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
ndc (package): 54973-4099-2
ndc (product): 54973-4099
ndc11 (package): 54973409902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54973-4099-2549734099021 CAN in 1 CARTON (54973-4099-2) / 18 g in 1 CAN1 can2026-04-22NoNoCurrent