FDA.reportPublic FDA data

Trauma Free

Product NDC
50164-0004
11-digit product format
501640004
Labeler code
50164
Product ID
50164-0004_6b7e4683-5d6e-42f3-be8d-369df0e3561c
Type
HUMAN OTC DRUG
Nonproprietary name
Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Magnesia Phosphorica, Ruta Graveolens, Arnica Montana
Dosage form
LIQUID
Route
ORAL
Labeler
Sago Natural Products
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-06-24
Marketing end
0000-00-00
Substance
COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; RUTA GRAVEOLENS FLOWERING TOP; ARNICA MONTANA
Active strength
6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct50164-0004DDiscontinued by firm2026-10-05
excluded packagepackage50164-000450164-0004-1DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50164-0004-1Trauma Free60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50164-0004TRAUMA FREE (SYMPHYTUM OFFICINALE, BELLIS PERENNIS, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, RUTA GRAVEOLENS, ARNICA MONTANA) LIQUID [SAGO NATURAL PRODUCTS]1Legacy NDC, 1 package rows20160628_8cc1c00c-6f37-49b5-88a8-4048c3a4fa96.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50164-0004-15016400040160 mL in 1 BOTTLE, DROPPER (50164-0004-1) 60 ml2016-06-240000-00-00NoNoCurrent