Spring Gene

Product NDC
63404-2501
11-digit product format
634042501
Labeler code
63404
Product ID
63404-2501_ac2cea2c-c177-4df7-ad94-9d3dee8e4b2b
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Health and Natural Beauty USA Corp
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-01
Substance
POTASSIUM NITRATE
Active strength
55 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Spring Gene
Brand name suffix
Oil Pulling Sensitivity
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE55 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
294051e3-69ec-4190-8b03-fa34988376b7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63404-2501-1Spring Gene Oil Pulling Sensitivity100 g in 1 TUBEPASTE, DENTIFRICE1001
63404-2501-1Spring Gene Oil Pulling Sensitivity1 in 1 CARTONPASTE, DENTIFRICE11

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 15 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Sensitive Whitening TPSODIUM FLUORIDETargetab9a129e-337b-31fe-e053-2995a90ac6912025-11-14WarningsExact identifier
application number: M022
Signature Care Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDESafeway83225fe5-0490-eb4b-e053-2a91aa0a68792025-11-14WarningsExact identifier
application number: M022
Rite Aid Extra WhiteningFLUORIDERite Aidefe2c6c1-b8c6-4a52-b3c6-c9bfca4505702025-11-14WarningsExact identifier
application number: M022
Sound Body Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEBig Lots Stores, Inc.81a0a712-76e1-133f-e053-2a91aa0a001a2025-11-14WarningsExact identifier
application number: M022
Top Care Enamel GuardFLUORIDETOPCO Assoc. LLC8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c2025-11-14WarningsExact identifier
application number: M022
Care One Maximum StrengthFLUORIDEAmerican Sales24715cc7-cf02-4ea0-a491-2a111ad3660e2025-11-14WarningsExact identifier
application number: M022
Kroger Enamel Protection Sensitive Gentle WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEKroger Company82b9a954-2a53-ac56-e053-2991aa0abd0e2025-11-13WarningsExact identifier
application number: M022
Sensitive Extra WhiteningSODIUM FLUORIDEPublix Super Market16eddce3-03e4-4c0e-e063-6294a90ae94d2025-11-13WarningsExact identifier
application number: M022
Pronamel Repair WhiteningPRONAMEL REPAIR WHITENINGPublix Super Market Inc16ee2625-3641-205d-e063-6394a90a742f2025-11-13WarningsExact identifier
application number: M022
Rite Aid Maximum StrengthBENZOCAINERite Aid340ccdab-0a02-454c-8d44-ced5667276ab2025-11-13WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINECVSa7572c4f-089b-0e80-e053-2a95a90a0ddf2025-11-13WarningsExact identifier
application number: M022
3x Medicated Mouth Sore GelBENZOCAINEWalgreensad509f2a-05de-6c77-e053-2995a90ae5262025-11-13WarningsExact identifier
application number: M022
TopCare Oral Pain Relief Maximum StrengthBENZOCAINETopco Associates LLC835fb6ac-dbb7-5566-e053-2991aa0af5e22025-11-13WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINEWalgreensa71c47de-d35d-49da-e053-2995a90a823c2025-11-13WarningsExact identifier
application number: M022
4X Medicated Toothache and Gum GelBENZOCAINEWalmarta471a858-edbf-c31e-e053-2995a90a71562025-11-13WarningsExact identifier
application number: M022
4X Medicated Severe Toothache and Gum CreamBENZOCAINERite Aid996fdbeb-1fe3-77b6-e053-2995a90a25c72025-11-13WarningsExact identifier
application number: M022
Topco 4x Medicated Toothache and Gum GelBENZOCAINETopCareb463ea94-08a9-ca5d-e053-2a95a90a224b2025-11-13WarningsExact identifier
application number: M022
4X Medicated Severe Toothache and Gum GelBENZOCAINERite Aid99703bf4-f169-5e05-e053-2995a90afab42025-11-13WarningsExact identifier
application number: M022
3X Medicated Mouth Sore GelBENZOCAINERite Aid997064c9-24bb-7fb1-e053-2995a90ace7c2025-11-13WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC8d187823-7e56-441b-8bca-8f03e7bb07c72025-11-12WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63404-2501-1634042501011 TUBE in 1 CARTON (63404-2501-1) / 100 g in 1 TUBE1 tube2026-03-01NoNoCurrent