FDA.reportPublic FDA data

Migraine

Product NDC
51393-7588
11-digit product format
513937588
Labeler code
51393
Product ID
51393-7588_0e50403b-de8a-4788-af58-5b123cf7df96
Type
HUMAN OTC DRUG
Nonproprietary name
Iris Versicolor Root and Sodium Chloride
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Forces of Nature
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2011-12-01
Marketing end
0000-00-00
Substance
IRIS VERSICOLOR ROOT; SODIUM CHLORIDE
Active strength
30 [hp_X]/100mL; [hp_C]/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51393-7588IInactivated by FDA2026-10-12
excluded packagepackage51393-758851393-7588-1IInactivated by FDA2026-10-12
excluded packagepackage51393-758851393-7588-2IInactivated by FDA2026-10-12
excluded packagepackage51393-758851393-7588-4IInactivated by FDA2026-10-12

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
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
51393-7588-12020-04-27Migraine Pain Management
51393-7588-22020-04-27Migraine Pain Management
51393-7588-42020-04-27Migraine Pain Management
51393-7588-12020-01-31Migraine Pain Management
51393-7588-22020-01-31Migraine Pain Management
51393-7588-42020-01-31Migraine Pain Management

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51393-7588-1Migraine Pain Management11 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS114
51393-7588-2Migraine Pain Management33 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS334
51393-7588-4Migraine Pain Management4 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS44

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQCMIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]2
Sodium ChlorideACTIVE INGREDIENT451W47IQ8XMIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]2
Iris Versicolor RootACTIVE MOIETYX43D4L3DQCMIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]2
Sodium CationACTIVE MOIETYLYR4M0NH37MIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]2
Chamaemelum Nobile Flower OilINACTIVE INGREDIENTUB27587839MIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]2
Lavandin OilINACTIVE INGREDIENT9RES347CKGMIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]2
Rosemary OilINACTIVE INGREDIENT8LGU7VM393MIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]2
Sesame OilINACTIVE INGREDIENTQX10HYY4QVMIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51393-7588MIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]4Legacy NDC, 3 package rows20200428_2d3faa4f-c0a0-4989-8fa6-689d0382e123.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51393-7588-15139375880111 mL in 1 BOTTLE, DISPENSING (51393-7588-1) 11 ml2011-12-010000-00-00NoNoCurrent
51393-7588-25139375880233 mL in 1 BOTTLE, DISPENSING (51393-7588-2) 33 ml2011-12-010000-00-00NoNoCurrent
51393-7588-4513937588044 mL in 1 BOTTLE, DISPENSING (51393-7588-4) 4 ml2016-07-010000-00-00NoNoCurrent