H-Insomnia Formula

Product NDC
61077-117
11-digit product format
610770117
Labeler code
61077
Product ID
61077-117_2906c142-d142-b339-e063-6294a90a4b76
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
2013-11-06
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

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct61077-117EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61077-11761077-117-33EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61077-11761077-117-11EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

Finished product
Yes
Brand name base
H-Insomnia Formula
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1G1EAA320LInternal UNII lookup
065C5D077JInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e3f5c322-e846-43b6-aa05-5777e6c14a70Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-117-11H-Insomnia Formula11 mL in 1 BOTTLE, DROPPEROIL113
61077-117-33H-Insomnia Formula33 mL in 1 BOTTLE, DROPPEROIL333

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-117H-INSOMNIA FORMULA (APIUM GRAVEOLENS, SALVIA OFFICINALIS) OIL [HEALING NATURAL OILS LLC]3Current NDC, Legacy NDC, 2 package rows20241213_e3f5c322-e846-43b6-aa05-5777e6c14a70.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H-Insomnia FormulaAPIUM GRAVEOLENS, SALVIA OFFICINALISHealing Natural Oils LLCe3f5c322-e846-43b6-aa05-5777e6c14a702024-12-11WarningsExact identifier
ndc (product): 61077-117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61077-117-116107701171111 mL in 1 BOTTLE, DROPPER (61077-117-11) 11 ml2013-11-060000-00-00NoNoCurrent
61077-117-336107701173333 mL in 1 BOTTLE, DROPPER (61077-117-33) 33 ml2013-11-060000-00-00NoNoCurrent