FDA.reportPublic FDA data

Nuby Soothing Gel

Manufacturer
NINGBO RAFFINI IMPORTS & EXPORTS CO LTD
Effective date
2025-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:31:32

Label at a glance#

ProductNuby Soothing Gel
Active ingredientTRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, ARNICA MONTANA ROOT
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

  • Arnica, radix 30X HPUS 3.33 %
  • Calcarea phosphorica 12XHPUS 3.33 %
  • Chamomilla 12X HPUS 3.33 %

1- ACTIVE INGREDIENTS1- ACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

  • Aqua (Purified Water)
  • Potassium Sorbate NF
  • Sodium Benzoate NF
  • Sorbic Acid NF
  • Vegetable Glycerin USP
  • Xantham Gum NF

2- INACTIVE INGREDIENTS2- INACTIVE INGREDIENTS

OTC - PURPOSE SECTION

Temporarily relieves sore gums, pain, and irritability due to oral discomfort.

3- Purpose and Uses3- Purpose and Uses

WARNINGS SECTION

Counsult a Physician if

  • symptoms persist for more than 72 hours or worsen
  • irritation, pain, or redness persits or worsen
  • rash or fever develops
  • swelling increases

5- WARNINGS5- WARNINGS

INSTRUCTIONS FOR USE SECTION

  • Wash hands before use
  • Cut open tip of tube on score mark
  • Use your fingertip or cotton applicator to gently apply a small pea-sized maount of Dr. Talbot's Soothing Gel to the affected area 15 miniutes as neccassary or as directed by a physician or health provider

6 - Directions6 - Directions

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of the reach of children.

In case of accidental overdose, contact a medical professional or a Poison Control immidiately.

7- KEEP OUT OF REACH OF CHILDREN7- KEEP OUT OF REACH OF CHILDREN

OTC - QUESTIONS SECTION

Call us at 1-855-366-7755 (U.S.A. only) M-F 8 am - 5 pm CT

8- QUESTIONS OR COMMENTS8- QUESTIONS OR COMMENTS

OTHER SAFETY INFORMATION

Tamper evident - Do not use if tube tip is cut prior to opening

10- OTHER INFORMATION10- OTHER INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DR. Talbot's

Soothing Gel

Naturally Inspired

Soothes sore Gums

with Chamomile

Benzocaine/Belladonna free

9- PRINCIPAL DISPLAY PANEL9- PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85182-240-04Nuby Soothing Gel1 in 1 BLISTER PACKGEL11
85182-240-15Nuby Soothing Gel15 g in 1 TUBEGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85182-240NUBY SOOTHING GEL (SOOTHING GEL) GEL [NINGBO RAFFINI IMPORTS & EXPORTS CO LTD]1Current NDC, 2 package rows20250125_290692c0-54d9-d401-e063-6294a90a705a.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85182-24085182-240-15, 85182-240-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
ARNICA MONTANA ROOTMUE8Y11327ACTIB
SORBIC ACIDX045WJ989BIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCERINPDC6A3C0OXIACT

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
Nuby Soothing GelSOOTHING GELNINGBO RAFFINI IMPORTS & EXPORTS CO LTD290692c0-54d9-d401-e063-6294a90a705a2025-01-21WarningsExact identifier
ndc (package): 85182-240-15
ndc (package): 85182-240-04
ndc (product): 85182-240
ndc11 (package): 85182024004
ndc11 (package): 85182024015
spl id: 290692c0-54da-d401-e063-6294a90a705a
spl set id: 290692c0-54d9-d401-e063-6294a90a705a

Reported adverse events (FAERS/openFDA)#

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