Royal Jelly Scar Balm

Product NDC
68828-004
11-digit product format
688280004
Labeler code
68828
Product ID
68828-004_2abe23d8-4c52-217d-e063-6394a90afbba
Type
HUMAN OTC DRUG
Nonproprietary name
DIMETHICONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Distribuidora Comercial Jafra, S.A. de C.V.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-15
Substance
DIMETHICONE
Active strength
2 g/100mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Royal Jelly Scar Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
244642Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27be84c1-0227-41ca-beb6-3855eff77e41Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01e96ee1-fe82-0132-025c-ec1559bf8b6eProduct name520260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cdProduct name320240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-004-01Royal Jelly Scar Balm1 in 1 CARTONCREAM14
68828-004-01Royal Jelly Scar Balm30 mL in 1 TUBECREAM304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-004ROYAL JELLY SCAR BALM (DIMETHICONE) CREAM [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.]4Current NDC, Legacy NDC, 2 package rows20250104_27be84c1-0227-41ca-beb6-3855eff77e41.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 38 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure LanaCareLANOLIN 30%Twin Med LLC3aad8395-6dc2-f600-e063-6294a90a6e9a2025-09-15WarningsExact identifier
application number: M016
ProCure DryDroxALUMINUM HYDROXIDE GEL 2%Twin Med LLC3ab4efb6-bd31-2583-e063-6294a90a415b2025-09-15WarningsExact identifier
application number: M016
ProCure Petroleum100% WHITE PETROLATUMTwin Med LLC3eddf0e7-8e9d-a311-e063-6394a90ad1562025-09-15WarningsExact identifier
application number: M016
NOURISHING HAND SANITIZER SPRAYSCHLORHEXIDINE DIGLUCONATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3e95a30c-8ed3-30ed-e063-6294a90a24172025-09-12WarningsExact identifier
application number: M016
I.C. Ivy BlockZINC ACETATER & R Lotion, Incdb263f4a-56a1-432c-b2e8-2a9bdd3ff1292025-09-10WarningsExact identifier
application number: M016
RoyceDerm Eczema Relief CreamCOLLOIDAL OATMEAL 1%RoyceDerm LLC3e09f000-01d2-0d21-e063-6294a90ac5482025-09-05WarningsExact identifier
application number: M016
Healing Hand CreamALLANTOINCarolina Cannabis Creations LLC3dd5887f-a26b-01ef-e063-6394a90a0c522025-09-02WarningsExact identifier
application number: M016
OKeeffes Skin Repair Body Cream Eczema ReliefCOLLOIDAL OATMEALThe Gorilla Glue Company/O'Keeffe's Company39e9ca98-d0e6-6b8f-e063-6394a90aa3662025-09-01WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3d379d5b-e939-9391-e063-6294a90a375c2025-08-25WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC3d1fd588-8d16-509c-e063-6394a90ad0252025-08-24WarningsExact identifier
application number: M016
Kidgets Baby Petroleum JellyBABY PETROLEUM JELLYMY IMPORTS USA LLC3d2000da-a173-1fc3-e063-6294a90ad3a92025-08-24WarningsExact identifier
application number: M016
Foaming Facial CleanserGLYCERIN, NIACINAMIDEGuangzhou Danting Bath&Body Care Industry Co. Ltd396c1db9-a5d3-cc82-e063-6294a90a90bb2025-08-23WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC3cf22c5a-f9a0-4bfb-e063-6394a90af8dd2025-08-22WarningsExact identifier
application number: M016
Kidgets Baby Petroleum Jelly with Vitamin A DLANOLIN, PETROLATUMMY IMPORTS USA LLC3cf37fa7-6be4-b835-e063-6394a90ad4062025-08-22WarningsExact identifier
application number: M016
Awaken Moisturizing CreamDIMETHICONEGuangzhou Danting Bath&Body Care Industry Co. Ltd486c7f05-708a-44a1-8fc0-78344f5018db2025-08-21WarningsExact identifier
application number: M016
Zinc Oxide 40%DIAPER RASH SKIN PROTECTENTELEEO BRANDS LLC2992285b-bcdb-c0da-e063-6294a90ac6502025-08-19WarningsExact identifier
application number: M016
MedPride Vitamin A and DWHITE PETROLATUMShield Line LLC360085ae-29fc-41c9-9875-c902f197a8712025-08-18WarningsExact identifier
application number: M016
Novita Petrolatum with Cocoa ButterPETROLATUMShield line LLC3e9c68e5-8983-1a18-e054-00144ff8d46c2025-08-18WarningsExact identifier
application number: M016
MedprideWHITE PETROLATUMShield Line LLC0c4201e1-54f5-4d44-a31a-89aaa511d6b52025-08-18WarningsExact identifier
application number: M016
Novita Baby Petrolatum JellyPETROLATUMShield Line LLC3e9cf8bf-929b-45bf-e054-00144ff8d46c2025-08-18WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244642dimethicone 2 % Topical CreamPSN27be84c1-0227-41ca-beb6-3855eff77e414
244642dimethicone 20 MG/ML Topical CreamSCD27be84c1-0227-41ca-beb6-3855eff77e414
244642dimethicone 2 % Topical CreamSY27be84c1-0227-41ca-beb6-3855eff77e414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68828-004-01688280004011 TUBE in 1 CARTON (68828-004-01) / 30 mL in 1 TUBE1 tube2022-06-150000-00-00NoNoCurrent