FDA.reportPublic FDA data

PRID

Product NDC
54973-4069
11-digit product format
549734069
Labeler code
54973
Product ID
54973-4069_2d71d23d-fcef-ffce-e063-6394a90a86da
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
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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.d22eca2f-d7e6-3412-e053-2995a90a63842025-02-05WarningsExact identifier
ndc (product): 54973-4069

Additional Listing Data#

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

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
d22eca2f-d7e6-3412-e053-2995a90a6384Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4069-1PRID1 in 1 CARTONSALVE15
54973-4069-1PRID18 g in 1 CANSALVE185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4069PRID (ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR) SALVE [HYLAND'S INC.]5Current NDC, Legacy NDC, 2 package rows20250207_d22eca2f-d7e6-3412-e053-2995a90a6384.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-4069-1549734069011 CAN in 1 CARTON (54973-4069-1) / 18 g in 1 CAN1 can2022-03-010000-00-00NoNoCurrent