Sleep Aid

Product NDC
57955-9986
11-digit product format
579559986
Labeler code
57955
Product ID
57955-9986_f38a3cc8-c70a-4b30-a7ea-db1055902a16
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Kali phosphoricum, Passiflora incarnata, Phosphorus, Pulsatilla, and Valeriana officinalis.
Dosage form
LIQUID
Route
ORAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-03-15
Substance
ACONITUM NAPELLUS WHOLE; AESCULUS HIPPOCASTANUM FLOWER; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; AVENA SATIVA FLOWERING TOP; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DIBASIC POTASSIUM PHOSPHATE; HYOSCYAMUS NIGER; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; STRYCHNOS IGNATII SEED; VALERIAN
Active strength
10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
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], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS WHOLE10 [hp_X]/59mL
AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]/59mL
ARSENIC TRIOXIDE10 [hp_X]/59mL
AVENA SATIVA FLOWERING TOP10 [hp_X]/59mL
ATROPA BELLADONNA10 [hp_X]/59mL
CAMPHOR (NATURAL)10 [hp_X]/59mL
CINCHONA OFFICINALIS BARK10 [hp_X]/59mL
ARABICA COFFEE BEAN10 [hp_X]/59mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT10 [hp_X]/59mL
HYOSCYAMUS NIGER10 [hp_X]/59mL
STRYCHNOS IGNATII SEED10 [hp_X]/59mL
DIBASIC POTASSIUM PHOSPHATE10 [hp_X]/59mL
PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]/59mL
PHOSPHORUS10 [hp_X]/59mL
PULSATILLA VULGARIS WHOLE10 [hp_X]/59mL
VALERIAN10 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U0NQ8555JDInternal UNII lookup
KK0Z92II8MInternal UNII lookup
S7V92P67HOInternal UNII lookup
MA9CQJ3F7FInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
N20HL7Q941Internal UNII lookup
S003A158SBInternal UNII lookup
3SW678MX72Internal UNII lookup
21Y9GZ1LZAInternal UNII lookup
4WRK2153H3Internal UNII lookup
1NM3M2487KInternal UNII lookup
CI71S98N1ZInternal UNII lookup
CLF5YFS11OInternal UNII lookup
27YLU75U4WInternal UNII lookup
I76KB35JEVInternal 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
794b7e4f-b084-4aee-8c07-96bac459d698Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-9986-2Sleep Aid59 mL in 1 BOTTLE, SPRAYLIQUID591

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
Sleep AidACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, PHOSPHORUS, PULSATILLA, AND VALERIANA OFFICINALIS.King Bio Inc.794b7e4f-b084-4aee-8c07-96bac459d6982026-03-04WarningsExact identifier
ndc (product): 57955-9986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57955-9986-25795599860259 mL in 1 BOTTLE, SPRAY (57955-9986-2) 59 ml2026-03-15NoNoCurrent