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
ARABICA COFFEE BEAN10 [hp_X]/mL
ARSENIC TRIOXIDE10 [hp_X]/mL
AVENA SATIVA FLOWERING TOP10 [hp_X]/mL
LACTIC ACID, L-8 [hp_X]/mL
MATRICARIA CHAMOMILLA WHOLE10 [hp_X]/mL
MELATONIN8 [hp_X]/mL
MERCURIC CHLORIDE10 [hp_X]/mL
PANTOTHENIC ACID8 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]/mL
PYRROLE8 [hp_X]/mL
SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS30 [hp_C]/mL
SHIGELLA DYSENTERIAE30 [hp_C]/mL
SILICON DIOXIDE10 [hp_X]/mL
SUS SCROFA PINEAL GLAND8 [hp_X]/mL
TRYPTOPHAN8 [hp_X]/mL
UBIDECARENONE8 [hp_X]/mL
ZINC VALERATE DIHYDRATE10 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5L51B4DR1G, 3SW678MX72, S7V92P67HO, MA9CQJ3F7F, F9S9FFU82N, G0R4UBI2ZZ, JL5DK93RCL, 53GH7MZT1R, 19F5HK2737, CLF5YFS11O, 86S1ZD6L2C, Y3V16D4PV4, 1EP6R5562J, ETJ7Z6XBU4, 050QZ2EDK7, 8DUH1N11BX, EJ27X76M46, MN0RX54EQA

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

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