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SPL v10

SPL

SPL Set ID 37f90a0f-2c67-456b-997e-8a8a4f5f09d3

Routes

dental topical

Published

Effective Date 2015-04-21

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.04 mg)

Inactive Ingredients

fd&c red no. 40

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

unapproved drug other active Since 2015-04-20

Medication Information

Section 43685-7

Section 51945-4

Structured Label Content

Section 43685-7 (43685-7)

Section 51945-4 (51945-4)

Advanced Ingredient Data

[{"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "0.04", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:49:38.238523 · Updated: 2026-03-14T22:49:18.583726