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 42 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Diabetics Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsfd6bf169-f1e2-48d4-b98d-8f3c39981a892025-05-23WarningsExact identifier
application number: M016
Perfect 10 Soothing RecoveryPETROLATUMTopiderm, Inc.e3a4f038-d084-4d77-bd35-13f41856a6152025-04-30WarningsExact identifier
application number: M016
Diabetic Advanced Healing CreamDIMETHICONENeoteric Cosmetics, Inc.46996845-9398-41d8-bf99-79f6a29bec282025-04-30WarningsExact identifier
application number: M016
BabyDiaperCreamBABY DIAPER CREAMWhole Foods Marketd7b19529-d0b2-638b-e053-2a95a90acf2f2025-04-29WarningsExact identifier
application number: M016
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
application number: M016
Assurance Barrier CreamDIMETHICONE CREAMWalmart Inc23a2a04f-71ce-4fa1-e063-6394a90a649e2025-04-22WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC21d2c0a0-70c3-7fd3-e063-6394a90a46d42025-04-18WarningsExact identifier
application number: M016
Secura Extra ProtectiveZINC OXIDESmith & Nephew Medical Ltd499a1944-1682-4798-9058-3748a5eaa4202025-04-17WarningsExact identifier
application number: M016
Firming Care GelFIRMING CARE GELGuangzhou Jiaan Cosmetics Co.,Ltd.32cb8a71-81cd-cdbd-e063-6394a90ac07f2025-04-15WarningsExact identifier
application number: M016
Baby Mantra Diaper CreamZINC OXIDE 10%Renu Laboratories, LLC0427bbc9-f4c0-0eb6-e063-6294a90a71992025-04-14WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELTOP CARE (Topco Associates LLC)23b592f7-3af3-45ef-897a-fe33ab518b6d2025-04-14WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELStrategic Sourcing Services LLCef3408db-de98-4a43-9215-f80fed14815c2025-04-14WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens69bdd508-7c33-42c5-9a08-e56cf3eaebf32025-04-11WarningsExact identifier
application number: M016
4% 10gTATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD322daa32-a74e-1fee-e063-6294a90a37aa2025-04-07WarningsExact identifier
application number: M016
Aluroderm ScarALLANTOINAsclemed USA, Inc.60656ca1-5218-4595-854e-19f1061def1e2025-04-01WarningsExact identifier
application number: M016
Dr. Maxs DiaperZINC OXIDEDr. Maxs LLC31bfa962-5e3b-c5d2-e063-6294a90ac1772025-04-01WarningsExact identifier
application number: M016
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
application number: M016
4% TATTOO Numb Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD31646815-f591-c560-e063-6294a90ad11a2025-03-28WarningsExact identifier
application number: M016
Face Saver GelSKIN PROTECTANT GELNeat Feat Products Limited31563dd7-9f58-80f6-e063-6294a90a55712025-03-27WarningsExact identifier
application number: M016
PorphoseCOLLOIDAL OATMEAL TOPICAL SPRAYPorphose315951e0-899f-c968-e063-6294a90abe612025-03-27WarningsExact 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