FDA.reportPublic FDA data

SINECCHi

Product NDC
63545-516
Requested package NDC
63545-516-04
11-digit product format
635450516
Labeler code
63545
Product ID
63545-516_2b491719-149a-ce7d-e063-6294a90ae655
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana
Dosage form
CAPSULE
Route
ORAL
Labeler
Hahnemann Laboratories Inc. dba Alpine Pharmaceuticals
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-02-21
Substance
ARNICA MONTANA
Active strength
1 [hp_M]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA1 [hp_M]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36ffb596-1c53-49e6-9228-5c2d378e1163Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-09-1936ffb596-1c53-49e6-9228-5c2d378e1163
2022-01-2836ffb596-1c53-49e6-9228-5c2d378e1163
2020-02-2436ffb596-1c53-49e6-9228-5c2d378e1163
2020-01-3136ffb596-1c53-49e6-9228-5c2d378e1163

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63545-516-01SINECCHi4 in 1 BLISTER PACKCAPSULE45
63545-516-02SINECCHi1 in 1 BOXCAPSULE15
63545-516-03SINECCHi12 in 1 BOXCAPSULE125
63545-516-04SINECCHi36 in 1 BOXCAPSULE365

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWSINECCHI (ARNICA MONTANA) CAPSULE [HAHNEMANN LABORATORIES, INC. DBA ALPINE PHARMACEUTICALS]2
ARNICA MONTANAACTIVE MOIETYO80TY208ZWSINECCHI (ARNICA MONTANA) CAPSULE [HAHNEMANN LABORATORIES, INC. DBA ALPINE PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SINECCHI (ARNICA MONTANA) CAPSULE [HAHNEMANN LABORATORIES, INC. DBA ALPINE PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSINECCHI (ARNICA MONTANA) CAPSULE [HAHNEMANN LABORATORIES, INC. DBA ALPINE PHARMACEUTICALS]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSINECCHI (ARNICA MONTANA) CAPSULE [HAHNEMANN LABORATORIES, INC. DBA ALPINE PHARMACEUTICALS]2
SUCROSEINACTIVE INGREDIENTC151H8M554SINECCHI (ARNICA MONTANA) CAPSULE [HAHNEMANN LABORATORIES, INC. DBA ALPINE PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINECCHI (ARNICA MONTANA) CAPSULE [HAHNEMANN LABORATORIES, INC. DBA ALPINE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63545-516SINECCHI (ARNICA MONTANA) CAPSULE [HAHNEMANN LABORATORIES INC. DBA ALPINE PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20250112_36ffb596-1c53-49e6-9228-5c2d378e1163.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
SINECCHiARNICA MONTANAHahnemann Laboratories Inc. dba Alpine Pharmaceuticals36ffb596-1c53-49e6-9228-5c2d378e11632025-01-09Exact identifier
ndc (package): 63545-516-04
ndc (product): 63545-516
ndc11 (package): 63545051604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63545-516-046354505160436 BOX in 1 BOX (63545-516-04) / 12 BOX in 1 BOX (63545-516-03) / 1 BLISTER PACK in 1 BOX (63545-516-02) / 4 CAPSULE in 1 BLISTER PACK (63545-516-01) 36 box2020-02-21NoNoCurrent