OHM Sleep Well

Product NDC
66096-727
11-digit product format
660960727
Labeler code
66096
Product ID
66096-727_d44bb081-9f15-afc7-e053-2995a90a7245
Type
HUMAN OTC DRUG
Nonproprietary name
Avena Sativa, Coffea Cruda, Ignatia Amara, Nux Vomica, Passiflora, Incarnata, Stramonium, Valeriana Officinalis.
Dosage form
LIQUID
Route
ORAL
Labeler
OHM PHARMA INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-04-21
Substance
AVENA SATIVA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; PASSIFLORA INCARNATA FLOWERING TOP; DATURA STRAMONIUM; VALERIAN
Active strength
4; 30; 12; 30; 4; 30; 4 [hp_X]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_C]/59mL; [hp_X]/59mL; [hp_C]/59mL; [hp_X]/59mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
OHM Sleep Well
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA FLOWERING TOP4 [hp_X]/59mL
ARABICA COFFEE BEAN30 [hp_C]/59mL
STRYCHNOS IGNATII SEED12 [hp_C]/59mL
STRYCHNOS NUX-VOMICA SEED30 [hp_C]/59mL
PASSIFLORA INCARNATA FLOWERING TOP4 [hp_X]/59mL
DATURA STRAMONIUM30 [hp_C]/59mL
VALERIAN4 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MA9CQJ3F7FInternal UNII lookup
3SW678MX72Internal UNII lookup
1NM3M2487KInternal UNII lookup
269XH13919Internal UNII lookup
CLF5YFS11OInternal UNII lookup
G6W4F0V8Z3Internal UNII lookup
JWF5YAW3QWInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9cac0195-8dca-4c53-891c-d834f7479e30Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-727-05OHM Sleep Well59 mL in 1 BOTTLE, GLASSLIQUID594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-727OHM SLEEP WELL (AVENA SATIVA, COFFEA CRUDA, IGNATIA AMARA, NUX VOMICA, PASSIFLORA, INCARNATA, STRAMONIUM, VALERIANA OFFICINALIS.) LIQUID [OHM PHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20211230_9cac0195-8dca-4c53-891c-d834f7479e30.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
OHM Sleep WellAVENA SATIVA, COFFEA CRUDA, IGNATIA AMARA, NUX VOMICA, PASSIFLORA, INCARNATA, STRAMONIUM, VALERIANA OFFICINALIS.OHM PHARMA INC.9cac0195-8dca-4c53-891c-d834f7479e302021-12-29WarningsExact identifier
ndc (product): 66096-727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66096-727-056609607270559 mL in 1 BOTTLE, GLASS (66096-727-05) 59 ml2017-04-210000-00-00NoNoCurrent