Dolodent

Product NDC
55758-324
11-digit product format
557580324
Labeler code
55758
Product ID
55758-324_f05e0234-9f94-cafa-e053-2995a90a9aa0
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana, Chamomilla, Hecla lava, Hypericum, Asafoedida
Dosage form
LIQUID
Route
BUCCAL
Labeler
Pharmadel LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-11-01
Marketing end
0000-00-00
Substance
ARNICA MONTANA; CHAMOMILE; FERULA ASSA-FOETIDA RESIN; HEKLA LAVA; HYPERICUM PERFORATUM
Active strength
30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55758-324DDiscontinued by firm2026-09-14
excluded packagepackage55758-32455758-324-15DDiscontinued by firm2026-09-14

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55758-324-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55758-324-15f5e01cc5f278…a2eaf40c39c3…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-324DOLODENT (ARNICA MONTANA, CHAMOMILLA, HECLA LAVA, HYPERICUM, ASAFOEDIDA) LIQUID [PHARMADEL LLC]9Legacy NDC20230912_ac3af7cf-e379-32c9-e053-2a95a90abae8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-324-15557580324151 BOTTLE in 1 BOX (55758-324-15) > 15 mL in 1 BOTTLE1 bottle2017-11-010000-00-00NoNoCurrent