FDA.reportPublic FDA data

3M Cavilon Durable Barrier

Product NDC
17518-030
11-digit product format
175180030
Labeler code
17518
Product ID
17518-030_d6078543-cbf7-42e2-b54f-7e2e5ab0f68a
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
Solventum US LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-01
Substance
DIMETHICONE
Active strength
13000 mg/L
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
3M Cavilon Durable Barrier
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE13000 mg/L

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
309916Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17518-030-013M Cavilon Durable Barrier0.0000273 L in 1 PACKETCREAM0.000027311
17518-030-013M Cavilon Durable Barrier240 in 1 CASECREAM24011
17518-030-023M Cavilon Durable Barrier0.000383 L in 1 TUBECREAM0.00038311
17518-030-023M Cavilon Durable Barrier12 in 1 CASECREAM1211
17518-030-033M Cavilon Durable Barrier12 in 1 CASECREAM1211
17518-030-033M Cavilon Durable Barrier0.00126 L in 1 TUBECREAM0.0012611
17518-030-043M Cavilon Durable Barrier0.0000273 L in 1 PACKETCREAM0.00002737
17518-030-053M Cavilon Durable Barrier0.000383 L in 1 TUBECREAM0.0003837
17518-030-063M Cavilon Durable Barrier0.00126 L in 1 TUBECREAM0.001267

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17518-030-02GM - Gram17518-030a095b4c7-30e9-4761-b167-23a355766d4112024-04-05
17518-030-03GM - Gram17518-030b3779a1e-8e2c-49c1-83fb-40e52c200b1012018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17518-0303M CAVILON DURABLE BARRIER (DIMETHICONE) CREAM [SOLVENTUM US LLC]10Current NDC, Legacy NDC, 6 package rows20240806_f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83.zip
17518-0303M CAVILON DURABLE BARRIER (DIMETHICONE) CREAM [SOLVENTUM US LLC]6Current NDC, Legacy NDC, 3 package rows20240806_42b95b12-d4e0-4069-bf60-56bbdb4afc1f.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 61 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Classic SpearmintPETROLATUMHaleon US Holdings LLCd39786e8-bcd8-479d-8990-142a21788a472024-04-12WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLCd6eb2ea6-27c7-40a6-a1f0-789ea2131de32024-04-11WarningsExact identifier
application number: M016
Chapstick Active 2in1 Variety PackZINC OXIDEHaleon US Holdings LLCd1998a9e-d61f-4b4c-91b0-5e66754bcc4a2024-04-11WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLC040694f0-b5ba-4203-bde9-699fa9b1afef2024-04-11WarningsExact identifier
application number: M016
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force FormulaOCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.3eb0f8ff-89e7-4410-8573-3349e49465482024-04-02WarningsExact identifier
application number: M016
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
application number: M016
ChapStick Supreme Classic CherryWHITE PETROLATUMHaleon US Holdings LLC84d8cc38-83e3-49be-b180-d01820525b602024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC9cd13fbb-887f-46a8-9f0b-4450ad3e07b72024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Peachy KeenZINC OXIDEHaleon US Holdings LLCef206fe7-2659-41dc-b117-380af704999b2024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Pretty in PinkZINC OXIDEHaleon US Holdings LLCe686ce23-57bc-4026-be62-d46d90ded4422024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Very BerryZINC OXIDEHaleon US Holdings LLC59023150-65ef-4427-9045-0e64b100cbab2024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLC33497c07-ad6e-4c50-bc23-a55725b2eae12024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCde250ae9-6e4a-46ca-bcc9-5bb07dbb70c52024-03-21WarningsExact identifier
application number: M016
ChapStick Classic StrawberryWHITE PETROLATUMHaleon US Holdings LLC3a279496-74c5-4ab1-ba69-06ad4a4f67cf2024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLCc1120c7a-1fa8-45a4-8bcf-35d9cc9f2c742024-03-21WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Sore Relief KitALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions523b6598-8039-4116-b0f8-ba31d7d6ea9d2024-03-20WarningsExact identifier
application number: M016
ChapStick Classic CherryWHITE PETROLATUMHaleon US Holdings LLCdb041b1b-084a-4283-b6ba-4d4bcdc220b32024-03-19WarningsExact identifier
application number: M016
ChapStick Classic OriginalWHITE PETROLATUMHaleon US Holdings LLC42fe0f4a-efb7-4e70-a359-db7dc2ac99052024-03-19WarningsExact identifier
application number: M016
ChapStick Classic SpearmintWHITE PETROLATUMHaleon US Holdings LLC74354d8e-c265-4a27-9715-1a4c157ad8902024-03-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309916dimethicone 1.3 % Topical CreamPSNf3f8be33-4ad2-4f5f-ac94-ddfbe0280b8311
309916dimethicone 13 MG/ML Topical CreamSCDf3f8be33-4ad2-4f5f-ac94-ddfbe0280b8311
309916dimethicone 0.65 GM per 50 ML Topical CreamSYf3f8be33-4ad2-4f5f-ac94-ddfbe0280b8311
309916dimethicone 1.3 % Topical CreamSYf3f8be33-4ad2-4f5f-ac94-ddfbe0280b8311
309916dimethicone 1.95 GM per 150 ML Topical CreamSYf3f8be33-4ad2-4f5f-ac94-ddfbe0280b8311
309916dimethicone 1.3 % Topical CreamPSN42b95b12-d4e0-4069-bf60-56bbdb4afc1f7
309916dimethicone 13 MG/ML Topical CreamSCD42b95b12-d4e0-4069-bf60-56bbdb4afc1f7
309916dimethicone 0.65 GM per 50 ML Topical CreamSY42b95b12-d4e0-4069-bf60-56bbdb4afc1f7
309916dimethicone 1.3 % Topical CreamSY42b95b12-d4e0-4069-bf60-56bbdb4afc1f7
309916dimethicone 1.95 GM per 150 ML Topical CreamSY42b95b12-d4e0-4069-bf60-56bbdb4afc1f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17518-030-0117518003001240 PACKET in 1 CASE (17518-030-01) / .0000273 L in 1 PACKET240 packet2016-06-010000-00-00NoNoCurrent
17518-030-021751800300212 TUBE in 1 CASE (17518-030-02) / .000383 L in 1 TUBE12 tube2016-06-010000-00-00NoNoCurrent
17518-030-031751800300312 TUBE in 1 CASE (17518-030-03) / .00126 L in 1 TUBE12 tube2016-06-010000-00-00NoNoCurrent
17518-030-04175180030040.0000273 L in 1 PACKET0.0000273 lHistorical
17518-030-05175180030050.000383 L in 1 TUBE0.000383 lHistorical
17518-030-06175180030060.00126 L in 1 TUBE0.00126 lHistorical