Home NDC 54973-3343-2 CANKER SORE HEALING DOTS
Product NDC 54973-3343
Requested package NDC 54973-3343-2
11-digit product format 549733343
Labeler code 54973
Product ID 54973-3343_ef4319d3-aec4-311a-e053-2995a90a00b8
Type HUMAN OTC DRUG
Nonproprietary name Sodium Borate, Calendula Officinalis Flowering Top, Causticum, Daphne Mezereum Bark and Sodium Chloride
Dosage form TABLET
Route ORAL
Labeler Hyland's Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2017-08-17
Marketing end 0000-00-00
Substance CALENDULA OFFICINALIS FLOWERING TOP; CAUSTICUM; DAPHNE MEZEREUM BARK; SODIUM BORATE; SODIUM CHLORIDE
Active strength 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54973-3343-2 54973334302 4 TABLET in 1 PACKET (54973-3343-2) 4 tablet 2017-08-17 0000-00-00 Yes No Current