FDA.reportPublic FDA data

Simple Chlorinated Combination

Product NDC
63083-9315
11-digit product format
630839315
Labeler code
63083
Product ID
63083-9315_bb7f067a-f505-405a-936e-89b11a60e36e
Type
HUMAN OTC DRUG
Nonproprietary name
Simple Chlorinated Combination
Dosage form
LIQUID
Route
ORAL
Labeler
Professional Complementary Health Formulas
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1984-08-15
Substance
BERBERIS VULGARIS ROOT BARK; BIS(2,4-DICHLOROBENZOYL) PEROXIDE; BLACK COHOSH; CARBON TETRACHLORIDE; CHELIDONIUM MAJUS WHOLE; CHLORINE; CHLOROFORM; ETHYLENE; GELSEMIUM SEMPERVIRENS ROOT; HEXACHLOROPHENE; STRYCHNOS NUX-VOMICA SEED; TRICHLOROETHYLENE
Active strength
10; 14; 3; 12; 10; 12; 12; 12; 3; 14; 6; 14 [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL; [hp_X]/29.5mL
Pharmacologic classes
Allergens [CS], Antiseptic [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], 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
Simple Chlorinated Combination
Brand name suffix
9315
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERBERIS VULGARIS ROOT BARK10 [hp_X]/29.5mL
BIS(2,4-DICHLOROBENZOYL) PEROXIDE14 [hp_X]/29.5mL
BLACK COHOSH3 [hp_X]/29.5mL
CARBON TETRACHLORIDE12 [hp_X]/29.5mL
CHELIDONIUM MAJUS WHOLE10 [hp_X]/29.5mL
CHLORINE12 [hp_X]/29.5mL
CHLOROFORM12 [hp_X]/29.5mL
ETHYLENE12 [hp_X]/29.5mL
GELSEMIUM SEMPERVIRENS ROOT3 [hp_X]/29.5mL
HEXACHLOROPHENE14 [hp_X]/29.5mL
STRYCHNOS NUX-VOMICA SEED6 [hp_X]/29.5mL
TRICHLOROETHYLENE14 [hp_X]/29.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1TH8Q20J0U, 0QC93Y0L96, K73E24S6X9, CL2T97X0V0, 7E889U5RNN, 4R7X1O2820, 7V31YC746X, 91GW059KN7, 639KR60Q1Q, IWW5FV6NK2, 269XH13919, 290YE8AR51

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
96bda7f6-d973-f357-e742-857a6dff43a6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9315-12026-01-09C16284748780-11030e365-5589-111a-e063-dadaa90a10e2R315
63083-9315-12026-01-09C16284748780-11030e365-5589-111a-e063-dadaa90a10e2R315
63083-9315-12024-01-30C16284748780-11030e365-5589-111a-e063-dadaa90a10e2R315
63083-9315-12024-01-30C16284748780-11030e365-5589-111a-e063-dadaa90a10e2R315

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9315-1Simple Chlorinated Combination931529.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63083-9315SIMPLE CHLORINATED COMBINATION 9315 (SIMPLE CHLORINATED COMBINATION) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS]1Current NDC, Legacy NDC, 1 package rows20220211_c1ab9a34-8a22-4840-ab8b-ef666dca155a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63083-9315-16308393150129.5 mL in 1 BOTTLE, DROPPER (63083-9315-1) 29.5 ml1985-08-150000-00-00NoNoCurrent