FDA.reportPublic FDA data

Kali Fluoratum

Manufacturer
Hahnemann Laboratories, INC.
Effective date
2023-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:15

Label at a glance#

ProductKali Fluoratum
Active ingredientPOTASSIUM FLUORIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kali Fluoratum 6C 5gKali Fluoratum 6C 5gKali Fluoratum 6C 30gKali Fluoratum 6C 30gKali Fluoratum 6C 100gKali Fluoratum 6C 100gKali Fluoratum 12C 5gKali Fluoratum 12C 5gKali Fluoratum 12C 30gKali Fluoratum 12C 30gKali Fluoratum 12C 100gKali Fluoratum 12C 100gKali Fluoratum 30C 1gKali Fluoratum 30C 1gKali Fluoratum 30C 5gKali Fluoratum 30C 5gKali Fluoratum 30C 30gKali Fluoratum 30C 30gKali Fluoratum 30C 100gKali Fluoratum 30C 100gKali Fluoratum 100C 1gKali Fluoratum 100C 1gKali Fluoratum 100C 5gKali Fluoratum 100C 5gKali Fluoratum 100C 30gKali Fluoratum 100C 30gKali Fluoratum 100C 100gKali Fluoratum 100C 100gKali Fluoratum 200C 1gKali Fluoratum 200C 1gKali Fluoratum 200C 5gKali Fluoratum 200C 5gKali Fluoratum 200C 30gKali Fluoratum 200C 30gKali Fluoratum 200C 100gKali Fluoratum 200C 100gKali Fluoratum 500C 1gKali Fluoratum 500C 1gKali Fluoratum 500C 5gKali Fluoratum 500C 5gKali Fluoratum 500C 30gKali Fluoratum 500C 30gKali Fluoratum 500C 100gKali Fluoratum 500C 100gKali Fluoratum 1M 1gKali Fluoratum 1M 1gKali Fluoratum 1M 5gKali Fluoratum 1M 5gKali Fluoratum 1M 30gKali Fluoratum 1M 30gKali Fluoratum 1M 100gKali Fluoratum 1M 100gKali Fluoratum LM1 30gKali Fluoratum LM1 30g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
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
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37662-3920-1Kali Fluoratum200 in 1 VIAL, GLASSPELLET2001
37662-3920-2Kali Fluoratum1200 in 1 BOTTLE, GLASSPELLET12001
37662-3920-3Kali Fluoratum4000 in 1 BOTTLE, GLASSPELLET40001
37662-3921-1Kali Fluoratum200 in 1 VIAL, GLASSPELLET2001
37662-3921-2Kali Fluoratum1200 in 1 BOTTLE, GLASSPELLET12001
37662-3921-3Kali Fluoratum4000 in 1 BOTTLE, GLASSPELLET40001
37662-3922-1Kali Fluoratum80 in 1 VIAL, GLASSPELLET801
37662-3922-2Kali Fluoratum200 in 1 VIAL, GLASSPELLET2001
37662-3922-3Kali Fluoratum1200 in 1 BOTTLE, GLASSPELLET12001
37662-3922-4Kali Fluoratum4000 in 1 BOTTLE, GLASSPELLET40001
37662-3923-1Kali Fluoratum200 in 1 VIAL, GLASSPELLET2001
37662-3923-2Kali Fluoratum500 in 1 VIAL, GLASSPELLET5001
37662-3923-3Kali Fluoratum3000 in 1 BOTTLE, GLASSPELLET30001
37662-3923-4Kali Fluoratum10000 in 1 BOTTLE, GLASSPELLET100001
37662-3924-1Kali Fluoratum200 in 1 VIAL, GLASSPELLET2001
37662-3924-2Kali Fluoratum500 in 1 VIAL, GLASSPELLET5001
37662-3924-3Kali Fluoratum3000 in 1 BOTTLE, GLASSPELLET30001
37662-3924-4Kali Fluoratum10000 in 1 BOTTLE, GLASSPELLET100001
37662-3925-1Kali Fluoratum200 in 1 VIAL, GLASSPELLET2001
37662-3925-2Kali Fluoratum500 in 1 VIAL, GLASSPELLET5001
37662-3925-3Kali Fluoratum3000 in 1 BOTTLE, GLASSPELLET30001
37662-3925-4Kali Fluoratum10000 in 1 BOTTLE, GLASSPELLET100001
37662-3926-1Kali Fluoratum200 in 1 VIAL, GLASSPELLET2001
37662-3926-2Kali Fluoratum500 in 1 VIAL, GLASSPELLET5001
37662-3926-3Kali Fluoratum3000 in 1 BOTTLE, GLASSPELLET30001
37662-3926-4Kali Fluoratum10000 in 1 BOTTLE, GLASSPELLET100001
37662-3927-1Kali Fluoratum10000 in 1 BOTTLE, GLASSPELLET100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37662-3920KALI FLUORATUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 3 package rows20230915_055aa7ce-89e5-cd78-e063-6394a90a7da6.zip
37662-3921KALI FLUORATUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 3 package rows20230915_055aa7ce-89e5-cd78-e063-6394a90a7da6.zip
37662-3922KALI FLUORATUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 4 package rows20230915_055aa7ce-89e5-cd78-e063-6394a90a7da6.zip
37662-3923KALI FLUORATUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 4 package rows20230915_055aa7ce-89e5-cd78-e063-6394a90a7da6.zip
37662-3924KALI FLUORATUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 4 package rows20230915_055aa7ce-89e5-cd78-e063-6394a90a7da6.zip
37662-3925KALI FLUORATUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 4 package rows20230915_055aa7ce-89e5-cd78-e063-6394a90a7da6.zip
37662-3926KALI FLUORATUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 4 package rows20230915_055aa7ce-89e5-cd78-e063-6394a90a7da6.zip
37662-3927KALI FLUORATUM PELLET [HAHNEMANN LABORATORIES, INC.]1Current NDC, 1 package rows20230915_055aa7ce-89e5-cd78-e063-6394a90a7da6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37662-392037662-3920-1, 37662-3920-2, 37662-3920-3
37662-392137662-3921-1, 37662-3921-2, 37662-3921-3
37662-392237662-3922-1, 37662-3922-2, 37662-3922-3, 37662-3922-4
37662-392337662-3923-1, 37662-3923-2, 37662-3923-3, 37662-3923-4
37662-392437662-3924-1, 37662-3924-2, 37662-3924-3, 37662-3924-4
37662-392537662-3925-1, 37662-3925-2, 37662-3925-3, 37662-3925-4
37662-392637662-3926-1, 37662-3926-2, 37662-3926-3, 37662-3926-4
37662-392737662-3927-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM FLUORIDE9082WG1G3FACTIB
SUCROSEC151H8M554IACT
POTASSIUM FLUORIDE9082WG1G3FACTIB
SUCROSEC151H8M554IACT
POTASSIUM FLUORIDE9082WG1G3FACTIB
SUCROSEC151H8M554IACT
POTASSIUM FLUORIDE9082WG1G3FACTIB
SUCROSEC151H8M554IACT
POTASSIUM FLUORIDE9082WG1G3FACTIB
SUCROSEC151H8M554IACT
POTASSIUM FLUORIDE9082WG1G3FACTIB
SUCROSEC151H8M554IACT
POTASSIUM FLUORIDE9082WG1G3FACTIB
SUCROSEC151H8M554IACT
POTASSIUM FLUORIDE9082WG1G3FACTIB
SUCROSEC151H8M554IACT

Source Document#

Source XML

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
Kali FluoratumKALI FLUORATUMHahnemann Laboratories, INC.055aa7ce-89e5-cd78-e063-6394a90a7da62023-09-14Exact identifier
ndc (package): 37662-3926-4
ndc (package): 37662-3920-1
ndc (package): 37662-3923-1
ndc (package): 37662-3927-1
ndc (package): 37662-3924-4
ndc (package): 37662-3925-4
ndc (package): 37662-3926-2
ndc (package): 37662-3921-1
ndc (package): 37662-3924-3
ndc (package): 37662-3922-3
ndc (package): 37662-3925-3
ndc (package): 37662-3924-2
ndc (package): 37662-3926-3
ndc (package): 37662-3923-4
ndc (package): 37662-3921-2
ndc (package): 37662-3925-2
ndc (package): 37662-3923-3
ndc (package): 37662-3921-3
ndc (package): 37662-3923-2
ndc (package): 37662-3924-1
ndc (package): 37662-3926-1
ndc (package): 37662-3920-3
ndc (package): 37662-3925-1
ndc (package): 37662-3922-2
ndc (package): 37662-3922-1
ndc (package): 37662-3920-2
ndc (package): 37662-3922-4
ndc (product): 37662-3925
ndc (product): 37662-3926
ndc (product): 37662-3927
ndc (product): 37662-3924
ndc (product): 37662-3923
ndc (product): 37662-3921
ndc (product): 37662-3920
ndc (product): 37662-3922
ndc11 (package): 37662392201
ndc11 (package): 37662392504
ndc11 (package): 37662392001
ndc11 (package): 37662392101
ndc11 (package): 37662392701
ndc11 (package): 37662392401
ndc11 (package): 37662392404
ndc11 (package): 37662392204
ndc11 (package): 37662392403
ndc11 (package): 37662392501
ndc11 (package): 37662392304
ndc11 (package): 37662392601
ndc11 (package): 37662392103
ndc11 (package): 37662392604
ndc11 (package): 37662392603
ndc11 (package): 37662392002
ndc11 (package): 37662392302
ndc11 (package): 37662392003
ndc11 (package): 37662392502
ndc11 (package): 37662392301
ndc11 (package): 37662392602
ndc11 (package): 37662392503
ndc11 (package): 37662392202
ndc11 (package): 37662392102
ndc11 (package): 37662392402
ndc11 (package): 37662392303
ndc11 (package): 37662392203
spl id: 055aa7ce-89e6-cd78-e063-6394a90a7da6
spl set id: 055aa7ce-89e5-cd78-e063-6394a90a7da6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.