FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose

Product NDC
49967-744
11-digit product format
499670744
Labeler code
49967
Product ID
49967-744_5b22b88e-f98b-d688-e063-6294a90a420b
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-15
Substance
DIMETHICONE
Active strength
10 mg/mL
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE10 mg/mL

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
200010Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
805cd262-2689-4818-8fed-ddefacbdde23Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-744-01La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose40 mL in 1 TUBECREAM406
49967-744-01La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose1 in 1 CARTONCREAM16
49967-744-02La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose3 mL in 1 TUBECREAM36
49967-744-02La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose1 in 1 CARTONCREAM16
49967-744-03La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose1 mL in 1 PACKETCREAM16
49967-744-04La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose100 mL in 1 TUBECREAM1006
49967-744-04La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-744LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 SOOTHING THERAPEUTIC MULTIPURPOSE (DIMETHICONE) CREAM [L'OREAL USA PRODUCTS INC]5Current NDC, Legacy NDC, 7 package rows20250321_805cd262-2689-4818-8fed-ddefacbdde23.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 40 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EIGHT HOUR SKIN FRAGRANCE FREEPETROLATUMREVLONb61d6e2e-18dd-37d2-e053-2a95a90af57b2025-08-01WarningsExact identifier
application number: M016
Vigority Wild Yam CreamESTRIOL CREAMFOUNDATION COMMERCE INC39b2bef7-46c5-9ad5-e063-6294a90ae9832025-07-30WarningsExact identifier
application number: M016
Rugby Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONRugby Laboratories9af3a740-ef97-26ce-e053-2a95a90a0ee12025-07-28WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Soothing Bath TreatmentOATMEALKenvue Brands LLCe7eb10b7-3950-49cb-ba73-11e7581b6be92025-07-25WarningsExact identifier
application number: M016
ProCure SkinGuardPETROLATUM 49.9%Twin Med LLC3a1721f6-1bb0-cd47-e063-6394a90a148e2025-07-25WarningsExact identifier
application number: M016
ProCure HydroCerinPETROLATUM 33%Twin Med LLC3ab7248d-b914-9fdd-e063-6294a90ac4c82025-07-24WarningsExact identifier
application number: M016
AD PREVENT OriginalAD PREVENT ORIGINALWellSpring Pharmaceutical Corporationcf73246e-81c1-42e9-a107-dc6c99cf7d012025-07-24WarningsExact identifier
application number: M016
Dimethicone 1 Skin ProtectantDIMETHICONEUniversal Distribution Center LLC2c5b96b9-24d6-4223-a63d-fe83d7c023682025-07-24WarningsExact identifier
application number: M016
Dr Butlers Soothing IncontinenceMINERAL OIL 59.8%, PETROLATUM 36.0%Beyond Health PA3a9d3796-fd05-fe57-e063-6294a90a0ac62025-07-23WarningsExact identifier
application number: M016
A and D plus EVITAMIN A, D AND E OINTMENTDerma Sciences Canada Inc.35aca592-bfd0-652f-e063-6394a90ac53e2025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMDerma Sciences Canada Inc.3a895e6c-da8d-db9b-e063-6394a90ace402025-07-22WarningsExact identifier
application number: M016
Petroleum JellyPETROLEUM JELLYNeilMed Pharmaceuticals Inc.36bbbb1e-78e9-98f6-e063-6294a90a66d12025-07-21WarningsExact identifier
application number: M016
Mountain Ice EczemaCOLLOIDAL OATMEALMountainside Medical Equipment, Inc.1a91f33e-dd85-4d5a-b61c-e460a507e2922025-07-21WarningsExact identifier
application number: M016
Our Eczema RemedyCOLLOIDAL OATMEALFewer Better Things3a755b4c-47c8-9ca5-e063-6394a90af84a2025-07-21WarningsExact identifier
application number: M016
Aveeno DAILY MOISTURIZINGDIMETHICONEKenvue Brands LLC54a13b85-32b5-439d-a27a-8fba2cf442512025-07-16WarningsExact identifier
application number: M016
ProCure Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
application number: M016
Avalon Organics Antidandruff ConditionerSALICYLIC ACIDThe Hain Celestial Group, Inc.66db1071-022a-aa19-e053-2a91aa0a8e392025-07-11WarningsExact identifier
application number: M016
Avalon Organics AntidandruffSALICYLIC ACIDThe Hain Celestial Group, Inc.66c7f730-64f3-4eef-e053-2a91aa0a42252025-07-11WarningsExact identifier
application number: M016
terrasil Infection Protection Wound Care Maximum StrengthALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9e7843e2-ca69-40f5-a4ce-da6b03ebe7f72025-07-11WarningsExact identifier
application number: M016
terrasil Skin RepairALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions92a23c7f-6b89-49cb-93e2-49ab7a85c86d2025-07-11WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200010dimethicone 1 % Topical CreamPSN805cd262-2689-4818-8fed-ddefacbdde236
200010dimethicone 10 MG/ML Topical CreamSCD805cd262-2689-4818-8fed-ddefacbdde236
200010dimethicone 1 % Topical CreamSY805cd262-2689-4818-8fed-ddefacbdde236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-744-01499670744011 TUBE in 1 CARTON (49967-744-01) / 40 mL in 1 TUBE1 tube2021-03-150000-00-00NoNoCurrent
49967-744-02499670744021 TUBE in 1 CARTON (49967-744-02) / 3 mL in 1 TUBE1 tube2021-03-150000-00-00NoNoCurrent
49967-744-03499670744031 mL in 1 PACKET (49967-744-03) 1 ml2021-03-150000-00-00NoNoCurrent
49967-744-04499670744041 TUBE in 1 CARTON (49967-744-04) / 100 mL in 1 TUBE1 tube2023-01-01NoNoCurrent