Sleep Aid

Product NDC
70558-0011
11-digit product format
705580011
Labeler code
70558
Product ID
70558-0011_88a30ca1-a920-4b4a-aa8f-2c7e92777efd
Type
HUMAN OTC DRUG
Nonproprietary name
Adenosinum Triphosphoricum Dinatrum, Pantothenic Acid, Pineal Gland (Suis), Sarcolacticum Acidum, Ubidecarenonum, L-Tryptophan, Melatonin, Pyrrole, Arsenicum Album, Avena Sativa, Chamomilla, Coffea Cruda, Mercurius Corrosivus, Passiflora Incarnata, Silicea, Zincum Valerianicum, Dysentery Bacillus, Gaertner Bacillus (Bach)
Dosage form
LIQUID
Route
ORAL
Labeler
Pro Weight Loss Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-07-16
Substance
ADENOSINE TRIPHOSPHATE DISODIUM; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; LACTIC ACID, L-; MATRICARIA CHAMOMILLA WHOLE; MELATONIN; MERCURIC CHLORIDE; PANTOTHENIC ACID; PASSIFLORA INCARNATA FLOWERING TOP; PYRROLE; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; SHIGELLA DYSENTERIAE; SILICON DIOXIDE; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; UBIDECARENONE; ZINC VALERATE DIHYDRATE
Active strength
8; 10; 10; 10; 8; 10; 8; 10; 8; 10; 8; 30; 30; 10; 8; 8; 8; 10 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADENOSINE TRIPHOSPHATE DISODIUM8 [hp_X]/mL
PANTOTHENIC ACID10 [hp_X]/mL
SUS SCROFA PINEAL GLAND10 [hp_X]/mL
LACTIC ACID, L-10 [hp_X]/mL
UBIDECARENONE8 [hp_X]/mL
TRYPTOPHAN10 [hp_X]/mL
MELATONIN8 [hp_X]/mL
PYRROLE10 [hp_X]/mL
ARSENIC TRIOXIDE8 [hp_X]/mL
AVENA SATIVA FLOWERING TOP10 [hp_X]/mL
MATRICARIA CHAMOMILLA WHOLE8 [hp_X]/mL
ARABICA COFFEE BEAN30 [hp_C]/mL
MERCURIC CHLORIDE30 [hp_C]/mL
PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]/mL
SILICON DIOXIDE8 [hp_X]/mL
ZINC VALERATE DIHYDRATE8 [hp_X]/mL
SHIGELLA DYSENTERIAE8 [hp_X]/mL
SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS10 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5L51B4DR1GInternal UNII lookup
19F5HK2737Internal UNII lookup
050QZ2EDK7Internal UNII lookup
F9S9FFU82NInternal UNII lookup
EJ27X76M46Internal UNII lookup
8DUH1N11BXInternal UNII lookup
JL5DK93RCLInternal UNII lookup
86S1ZD6L2CInternal UNII lookup
S7V92P67HOInternal UNII lookup
MA9CQJ3F7FInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
3SW678MX72Internal UNII lookup
53GH7MZT1RInternal UNII lookup
CLF5YFS11OInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
MN0RX54EQAInternal UNII lookup
1EP6R5562JInternal UNII lookup
Y3V16D4PV4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d0af311a-e975-4236-8c0e-0418efa7e45fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70558-0011-1Sleep Aid30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70558-0011SLEEP AID (ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)) LIQUID [PRO WEIGHT LOSS INC.]1Current NDC, Legacy NDC, 1 package rows20210717_d0af311a-e975-4236-8c0e-0418efa7e45f.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
Sleep AidADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Pro Weight Loss Inc.d0af311a-e975-4236-8c0e-0418efa7e45f2021-07-16WarningsExact identifier
ndc (product): 70558-0011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70558-0011-17055800110130 mL in 1 BOTTLE, DROPPER (70558-0011-1) 30 ml2021-07-160000-00-00NoNoCurrent