FDA.reportPublic FDA data

Nuby Soothing Gel

Product NDC
85182-240
Requested package NDC
85182-240-04
11-digit product format
851820240
Labeler code
85182
Product ID
85182-240_290692c0-54da-d401-e063-6294a90a705a
Type
HUMAN OTC DRUG
Nonproprietary name
Soothing Gel
Dosage form
GEL
Route
TOPICAL
Labeler
NINGBO RAFFINI IMPORTS & EXPORTS CO LTD
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-01-21
Substance
ARNICA MONTANA ROOT; MATRICARIA RECUTITA; TRIBASIC CALCIUM PHOSPHATE
Active strength
30; 12; 12 [hp_X]/15g; [hp_X]/15g; [hp_X]/15g
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nuby Soothing Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIBASIC CALCIUM PHOSPHATE12 [hp_X]/15g
MATRICARIA RECUTITA12 [hp_X]/15g
ARNICA MONTANA ROOT30 [hp_X]/15g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91D9GV0Z28Internal UNII lookup
G0R4UBI2ZZInternal UNII lookup
MUE8Y11327Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
290692c0-54d9-d401-e063-6294a90a705aAvailable on FDA.report

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

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): 85182-240-04
ndc (product): 85182-240
ndc11 (package): 85182024004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85182-240-04851820240041 TUBE in 1 BLISTER PACK (85182-240-04) / 15 g in 1 TUBE (85182-240-15) 1 tube2025-01-21NoNoCurrent