FDA.reportPublic FDA data

Sleep Aid Formula

Product NDC
61077-118
11-digit product format
610770118
Labeler code
61077
Product ID
61077-118_60aff70b-dbd8-49a4-8d7a-c4ad61d66545
Type
HUMAN OTC DRUG
Nonproprietary name
apium graveolens, salvia officinalis
Dosage form
OIL
Route
TOPICAL
Labeler
Healing Natural Oils LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-11-22
Substance
CELERY SEED; SAGE
Active strength
6; 6 [hp_C]/11mL; [hp_C]/11mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELERY SEED6 [hp_C]/11mL
SAGE6 [hp_C]/11mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1G1EAA320L, 065C5D077J

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-118-11Sleep Aid Formula11 mL in 1 BOTTLE, DROPPEROIL113
61077-118-33Sleep Aid Formula33 mL in 1 BOTTLE, DROPPEROIL333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-118SLEEP AID FORMULA (APIUM GRAVEOLENS, SALVIA OFFICINALIS) OIL [HEALING NATURAL OILS LLC]3Current NDC, Legacy NDC, 2 package rows20171228_ece921fa-350a-4135-a616-18f4d438ac1a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61077-118-116107701181111 mL in 1 BOTTLE, DROPPER (61077-118-11) 11 ml2016-11-220000-00-00NoNoCurrent
61077-118-336107701183333 mL in 1 BOTTLE, DROPPER (61077-118-33) 33 ml2016-11-220000-00-00NoNoCurrent