FDA.reportPublic FDA data

Acne Relief Gel

Product NDC
66096-747
Requested package NDC
66096-747-03
11-digit product format
660960747
Labeler code
66096
Product ID
66096-747_d44ae412-0004-a536-e053-2a95a90af73f
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula Officinalis, Chamomilla, Berberis Aquafolium, Hamamelis, Hepar Sulph. Calc. , Sulphur
Dosage form
GEL
Route
TOPICAL
Labeler
OHM PHARMA INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-11-29
Substance
CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA CHAMOMILLA; BERBERIS AQUIFOLIUM ROOT BARK; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; CALCIUM SULFIDE; SULFUR
Active strength
1; 1; 2; 2; 6; 6 [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g; [hp_X]/50g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Acne Relief Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/50g
MATRICARIA CHAMOMILLA1 [hp_X]/50g
BERBERIS AQUIFOLIUM ROOT BARK2 [hp_X]/50g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK2 [hp_X]/50g
CALCIUM SULFIDE6 [hp_X]/50g
SULFUR6 [hp_X]/50g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
18E7415PXQInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
VZJ9F3C3SBInternal UNII lookup
T7S323PKJSInternal UNII lookup
1MBW07J51QInternal 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
43f669ef-2ebd-46c8-adb6-84bea30a7c0bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-747-03Acne Relief Gel50 g in 1 TUBEGEL503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-747ACNE RELIEF GEL (CALENDULA OFFICINALIS, CHAMOMILLA, BERBERIS AQUAFOLIUM, HAMAMELIS, HEPAR SULPH. CALC. , SULPHUR) GEL [OHM PHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20211230_43f669ef-2ebd-46c8-adb6-84bea30a7c0b.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
Acne Relief GelCALENDULA OFFICINALIS, CHAMOMILLA, BERBERIS AQUAFOLIUM, HAMAMELIS, HEPAR SULPH. CALC. , SULPHUROHM PHARMA INC.43f669ef-2ebd-46c8-adb6-84bea30a7c0b2021-12-29WarningsExact identifier
ndc (package): 66096-747-03
ndc (product): 66096-747
ndc11 (package): 66096074703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66096-747-036609607470350 g in 1 TUBE (66096-747-03) 50 g2018-11-290000-00-00NoNoCurrent