Melatonin Pro

Product NDC
44911-0500
11-digit product format
449110500
Labeler code
44911
Product ID
44911-0500_bdfbe914-ba46-48a2-885f-a5c8b74c8f7b
Type
HUMAN OTC DRUG
Nonproprietary name
Calcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (Pratensis)
Dosage form
TABLET
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-07
Substance
ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; DIBASIC POTASSIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; MAGNESIUM CARBONATE; MATRICARIA CHAMOMILLA; MELATONIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA PRATENSIS WHOLE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED
Active strength
12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
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

Additional Listing Data#

Finished product
Yes
Brand name base
Melatonin Pro
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANAMIRTA COCCULUS SEED12 [hp_X]/1
ARABICA COFFEE BEAN12 [hp_X]/1
DIBASIC POTASSIUM PHOSPHATE12 [hp_X]/1
FERROSOFERRIC PHOSPHATE12 [hp_X]/1
MAGNESIUM CARBONATE12 [hp_X]/1
MATRICARIA CHAMOMILLA12 [hp_X]/1
MELATONIN12 [hp_X]/1
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/1
PULSATILLA PRATENSIS WHOLE12 [hp_X]/1
SODIUM CHLORIDE12 [hp_X]/1
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii810258W28U, 3SW678MX72, CI71S98N1Z, 91GQH8I5F7, 0E53J927NA, G0R4UBI2ZZ, JL5DK93RCL, 2E32821G6I, 8E272251DI, 451W47IQ8X, 269XH13919

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0500-12022-03-10C16284748780-1ba0f9c33-12e4-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0500-12021-01-29C16284748780-1ba0f9c33-12e4-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0500-1Melatonin Pro60 in 1 BOTTLE, PLASTICTABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0500MELATONIN PRO (CALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)) TABLET [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20230722_1f374642-83f7-4e64-b330-0f6ef21000a9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0500-14491105000160 TABLET in 1 BOTTLE, PLASTIC (44911-0500-1) 60 tablet2019-06-072024-06-19NoNoCurrent