FDA.reportPublic FDA data

Gracie Square Hospital Amenity

Manufacturer
ASP Global, LLc | Shengzhou Kingbird Travel Products Co., Ltd. | Colgate-Palmolive (Thailand) LTD
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:29:20

Label at a glance#

ProductGracie Square Hospital Amenity
Active ingredientSodium Monofluorophosphate
Label structure11 sections

Dosage and administration

adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Colgate® Anticavity Toothpaste

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.15%)w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

dicalcium phosphate dihydrate, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour), cellulose gum, tetrasodium pyrophosphate, sodium saccharin, limonene

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-468-6502

SPL UNCLASSIFIED SECTION

Manufactured by:
COLGATE-PALMOLIVE (THAILAND) Limited, Chonburi 20000, Thailand.

PRINCIPAL DISPLAY PANEL - 10 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Toothpaste

Cavity
Protection

NET WT 10g

Principal Display Panel - 10 g Tube Label
Principal Display Panel - 10 g Tube Label

PRINCIPAL DISPLAY PANEL - Kit Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GRACIE
SQUARE
HOSPITAL

Item #: GSHAMEN01

Description: Amenity Kit

PO #:

Lot #: XMMDDFC

Exp: YYYY-MM-DD

Qty: 20 KIT/CS

Carton #: X of XX

Net Wt.: XX KG

Gross Wt.: XX KG

Cubic Dimensions: NN x NN x NN CM

Assembled in China

Components Made in China:

  • Shampoo/Conditioner
  • Body Wash
  • Body Lotion
  • Alcohol-Free Mouthwash
  • Hair Brush
  • Toothbrush
  • Ear Plugs
  • Lip Balm
  • Kit Case

Component Made in Thailand:

  • Toothpaste

GRACIE
SQUARE
HOSPITAL

We are pleased to
present this welcome kit
for your comfort and
convenience during your
stay.

Thank you for choosing
Gracie Square Hospital
for your healthcare!

Contents/Origins:

2.0 fl. oz. Shampoo/Conditioner
2.0 fl. oz. Body Wash
2.0 fl. oz. Body Lotion
2.2 fl. oz. Alcohol-Free Mouthwash
0.15 oz. net wt. Lip Balm
Hair Brush, Toothbrush, Ear Plugs,
and Kit Case: Made in China
Toothpaste: Made in Thailand

Lot #:
Exp:

Distributed by:
ASP Global, LLC
3450 Atlanta Industrial Parkway
Atlanta, GA 30331

GSHAMEN01 Rev 2

GRACIE
SQUARE
HOSPITAL

Principal Display Panel - Kit Label
Principal Display Panel - Kit Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN6
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59448-101-002025-12-30C16284748780-1d6a99b39-ec40-a426-e053-dadaa90af4c2Gracie Square Hospital Amenity Kit
59448-101-002022-01-28C16284748780-1d6a99b39-ec40-a426-e053-dadaa90af4c2Gracie Square Hospital Amenity Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-101-00Gracie Square Hospital Amenity1 in 1 BAGKIT16

Products#

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

DailyMed product names page 1 of 2 · 60 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59448-10159448-101-00
42555-06042555-060-45

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 75 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium MonofluorophosphateC810JCZ56QACTIM
Dibasic Calcium Phosphate DihydrateO7TSZ97GEPIACT
Water059QF0KO0RIACT
Sorbitol506T60A25RIACT
Sodium Lauryl Sulfate368GB5141JIACT
Sodium PyrophosphateO352864B8ZIACT
Saccharin SodiumSB8ZUX40TYIACT
Water059QF0KO0RINGR
ISOPROPYL PALMITATE8CRQ2TH63MINGR
CETOSTEARYL ALCOHOL2DMT128M1SINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
CYCLOMETHICONE 50THT5PCI0RINGR
ISOPROPYL MYRISTATE0RE8K4LNJSINGR
BENZYL ALCOHOLLKG8494WBHINGR
PEG-100 MONOSTEARATEYD01N1999RINGR
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EINGR
DEHYDROACETIC ACID2KAG279R6RINGR
SODIUM HYDROXIDE55X04QC32IINGR
WHITECOLR
Water059QF0KO0RINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
SODIUM CHLORIDE451W47IQ8XINGR
GLYCERINPDC6A3C0OXINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
COCO MONOETHANOLAMIDEC80684146DINGR
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW)U1G23TFV1KINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
MAGNESIUM NITRATE77CBG3UN78INGR
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNINGR
MAGNESIUM CHLORIDE02F3473H9OINGR
METHYLPARABENA2I8C7HI9TINGR
PROPYLPARABENZ8IX2SC1OHINGR
METHYLISOTHIAZOLINONE229D0E1QFAINGR
FD&C YELLOW NO. 5I753WB2F1MINGR
FD&C RED NO. 4X3W0AM1JLXINGR
YELLOWCOLR
Water059QF0KO0RINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
SODIUM CHLORIDE451W47IQ8XINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR

Source Document#

Source XML · Source PDF

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD.4ba81636-cdb7-e904-e063-6394a90a8bd52026-02-25WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
ndc (package): 42555-060-45
ndc (package): 59448-101-00
ndc (product): 59448-101
ndc11 (package): 42555006045
ndc11 (package): 59448010100
spl id: baaa5bdf-c58a-4b39-a6a6-dda6d98229fa
spl set id: 89d81053-6950-465e-a5b1-cbf841d7afcb
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Univ of Vermont Medical Center AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7841cfa9-e94e-4c3d-b5fb-6769240178452024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital Mothers VaginalALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7f1a85fd-086b-4fc7-abac-863dd3ea505a2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital H.E.A.R.T. Strings ToteALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLcf8369a27-1995-4fdd-a282-35c344c11d832024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital Amenity KitALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLc877ce875-c5b0-4d9b-8f00-682914e3bc0e2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Wellstar AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcced9dd96-7922-43d7-906f-32afaad733ec2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital C-Section MothersALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc9df6d0e9-631c-4619-9d96-d2c5a32a590e2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Memorial Sloan Kettering Cancer Center Amenity KitSODIUM MONOFLUOROPHOSPHATEASP Global, LLccab0bef1-f486-4eac-a61b-6030467d86502024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Sarasota Memorial AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcf5dda019-fcfd-4e99-89cc-e79e76b402e72024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Englewood AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7c9ce1bf-6aa2-4073-ad09-2ddf845102a22024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
ndc (package): 42555-060-45
ndc (product): 42555-060
ndc11 (package): 42555006045
Emory Johns Creek AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global952ccb85-71bb-4d5d-ac9b-62851a39d36d2024-12-04WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045

Reported adverse events (FAERS/openFDA)#

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