FDA.reportPublic FDA data

Sleep Well

Product NDC
51393-4014
11-digit product format
513934014
Labeler code
51393
Product ID
51393-4014_a3fa52f8-b478-4c2d-b4f7-57ea5eb87a26
Type
HUMAN OTC DRUG
Nonproprietary name
Avena Sativa Flowering Top, Arabica Coffee Bean, Lavandula Angustifolia Subsp. Angustifolia Flower, Macropiper Methysticum Root, and Valerian
Dosage form
SOLUTION/ DROPS
Route
TOPICAL
Labeler
Forces of Nature
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-09-01
Marketing end
0000-00-00
Substance
AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER; MACROPIPER METHYSTICUM ROOT; VALERIAN
Active strength
30 [hp_X]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51393-4014IInactivated by FDA2026-10-15
excluded packagepackage51393-401451393-4014-4IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-04-28Sleep Well Control
2020-04-28Sleep Well
2020-01-31Sleep Well Control
2020-01-31Sleep Well

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51393-4014-4Sleep Well Control4 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS43
51393-4014-4Sleep Well Control1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51393-4014SLEEP WELL CONTROL (AVENA SATIVA FLOWERING TOP, ARABICA COFFEE BEAN, LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER, MACROPIPER METHYSTICUM ROOT, AND VALERIAN) SOLUTION/ DROPS [FORCES OF NATURE]3Legacy NDC, 2 package rows20200429_0944a425-3e44-4a0c-9923-c506a80c8cba.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51393-4014-4513934014041 BOTTLE, DISPENSING in 1 CARTON (51393-4014-4) > 4 mL in 1 BOTTLE, DISPENSING2018-09-010000-00-00NoNoCurrent