Home NDC 63545-516-01 SINECCHi
Product NDC 63545-516
Requested package NDC 63545-516-01
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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base SINECCHi
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ARNICA MONTANA 1 [hp_M]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O80TY208ZW Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63545-516-01 SINECCHi 4 in 1 BLISTER PACK CAPSULE 4 5 63545-516-02 SINECCHi 1 in 1 BOX CAPSULE 1 5 63545-516-03 SINECCHi 12 in 1 BOX CAPSULE 12 5 63545-516-04 SINECCHi 36 in 1 BOX CAPSULE 36 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63545-516 SINECCHI (ARNICA MONTANA) CAPSULE [HAHNEMANN LABORATORIES INC. DBA ALPINE PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 4 package rows 20250112_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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63545-516-01 63545051601 4 CAPSULE in 1 BLISTER PACK (63545-516-01) 4 capsule 2020-02-21 0000-00-00 No No Current