FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose

Product NDC
69625-743
11-digit product format
696250743
Labeler code
69625
Product ID
69625-743_5b22cd9e-83b3-4537-e063-6394a90a2e3f
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmetique Active Production
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 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
d19f482c-bec7-45aa-b22f-fe91a3dc717dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69625-743-01La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose40 mL in 1 TUBECREAM403
69625-743-01La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose1 in 1 CARTONCREAM13
69625-743-02La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose3 mL in 1 TUBECREAM33
69625-743-02La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose1 in 1 CARTONCREAM13
69625-743-03La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose1 mL in 1 PACKETCREAM13
69625-743-04La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose100 mL in 1 TUBECREAM1003
69625-743-04La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69625-743LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 THERAPEUTIC MULTIPURPOSE (DIMETHICONE) CREAM [COSMETIQUE ACTIVE PRODUCTION]2Current NDC, 7 package rows20231212_d19f482c-bec7-45aa-b22f-fe91a3dc717d.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 4 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
application number: M016
AOAO RAPID ACNE RELIEFSALICYLIC ACID,BENZOYL PEROXIDEGuangzhou Senmai Biotechnology Co.,Ltd.586df874-0f71-ed46-e063-6294a90a0a8e2026-08-06WarningsExact identifier
application number: M016
Dealmed Vitamins A and DWHITE PETROLATUMDealmed Medical Supplies, LLC.d6584809-b438-4b2c-ab37-522e0dbef4702026-08-05WarningsExact identifier
application number: M016
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
application number: M016
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
application number: M016
PROCUREZINC OXIDETWIN MED, LLCe68ae97e-668e-31c2-e053-2995a90ab4d32026-08-03WarningsExact identifier
application number: M016
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
application number: M016
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
application number: M016
456 Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.5830fd36-0613-1980-e063-6294a90adfb72026-08-03WarningsExact identifier
application number: M016
Crogooe Skin Relief CreamCOLLOIDAL OATMEALGuangdong Outeli Biotechnology Co., Ltd.57f9b3e8-25d3-2b20-e063-6394a90aaea52026-08-01WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.57c3556a-aad3-3e65-e063-6394a90ab6892026-07-29WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
ATTITUDE Baby Leaves Diaper cream - UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)579aa481-f8ec-b263-e063-6394a90a77542026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200010dimethicone 1 % Topical CreamPSNd19f482c-bec7-45aa-b22f-fe91a3dc717d3
200010dimethicone 10 MG/ML Topical CreamSCDd19f482c-bec7-45aa-b22f-fe91a3dc717d3
200010dimethicone 1 % Topical CreamSYd19f482c-bec7-45aa-b22f-fe91a3dc717d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69625-743-01696250743011 TUBE in 1 CARTON (69625-743-01) / 40 mL in 1 TUBE1 tube2021-03-15NoNoCurrent
69625-743-02696250743021 TUBE in 1 CARTON (69625-743-02) / 3 mL in 1 TUBE1 tube2021-03-15NoNoCurrent
69625-743-03696250743031 mL in 1 PACKET (69625-743-03) 1 ml2021-03-15NoNoCurrent
69625-743-04696250743041 TUBE in 1 CARTON (69625-743-04) / 100 mL in 1 TUBE1 tube2023-01-01NoNoCurrent