Restless Leg Drops

Product NDC
63083-2172
11-digit product format
630832172
Labeler code
63083
Product ID
63083-2172_e9872a8e-5fe6-4c28-b911-14406a2d049b
Type
HUMAN OTC DRUG
Nonproprietary name
Restless Leg Drops
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
ACONITUM NAPELLUS WHOLE; ARSENIC TRIOXIDE; AVISCUMINE; CAUSTICUM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; RHODODENDRON TOMENTOSUM LEAFY TWIG; STRYCHNOS IGNATII SEED; SULFUR; TOXICODENDRON PUBESCENS LEAF; ZINC
Active strength
6; 12; 4; 12; 8; 4; 6; 6; 6; 6; 12 [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
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Restless Leg Drops
Brand name suffix
2172
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS WHOLE6 [hp_X]/59mL
ARSENIC TRIOXIDE12 [hp_X]/59mL
AVISCUMINE4 [hp_X]/59mL
CAUSTICUM12 [hp_X]/59mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]/59mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE4 [hp_X]/59mL
RHODODENDRON TOMENTOSUM LEAFY TWIG6 [hp_X]/59mL
STRYCHNOS IGNATII SEED6 [hp_X]/59mL
SULFUR6 [hp_X]/59mL
TOXICODENDRON PUBESCENS LEAF6 [hp_X]/59mL
ZINC12 [hp_X]/59mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, S7V92P67HO, 4B18YVW82N, DD5FO1WKFU, HF539G9L3Q, 36XQ854NWW, 877L01IZ0P, 1NM3M2487K, 70FD1KFU70, 6IO182RP7A, J41CSQ7QDS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2172-22026-01-09C16284748780-11030e365-29dc-111a-e063-dadaa90a10e2C172
63083-2172-22026-01-09C16284748780-11030e365-29dc-111a-e063-dadaa90a10e2C172
63083-2172-22024-01-30C16284748780-11030e365-29dc-111a-e063-dadaa90a10e2C172
63083-2172-22024-01-30C16284748780-11030e365-29dc-111a-e063-dadaa90a10e2C172

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2172-2Restless Leg Drops217259 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-2172RESTLESS LEG DROPS 2172 (RESTLESS LEG DROPS) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220216_73822225-f10c-4d2a-8cd8-ea31dd2b2789.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-2172-26308321720259 mL in 1 BOTTLE, DROPPER (63083-2172-2) 59 ml1985-08-150000-00-00NoNoCurrent