FDA.reportPublic FDA data

Chamosyn

Product NDC
51028-003
11-digit product format
510280003
Labeler code
51028
Product ID
51028-003_34a97f44-835c-ebb7-e063-6294a90a5b67
Type
HUMAN OTC DRUG
Nonproprietary name
Barrier Cream
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Links Medical Products
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-01
Substance
MENTHOL; ZINC OXIDE
Active strength
4.5; 200 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chamosyn
Brand name suffix
Paraben Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4.5 mg/g
ZINC OXIDE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z, L7T10EIP3A
Rxcui884804, 1998442, 2730301

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51028-003-002023-10-16C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey
51028-003-012023-10-16C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey
51028-003-002021-07-23C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey
51028-003-012021-07-23C16284748780-1c7ccaba7-2130-fd44-e053-dadaa90aa01bChamosyn with Manuka Honey

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51028-003-00ChamosynParaben Free5 g in 1 PACKETOINTMENT58
51028-003-00ChamosynParaben Free144 in 1 BOXOINTMENT1448
51028-003-01ChamosynParaben Free113 g in 1 TUBEOINTMENT1138

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51028-003CHAMOSYN PARABEN FREE (BARRIER CREAM) OINTMENT CHAMOSYN (BARRIER CREAM) OINTMENT [LINKS MEDICAL PRODUCTS]7Current NDC, Legacy NDC, 3 package rows20241215_f9dfb2d7-4684-4525-994e-1e0ff90413d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2730301Chamosyn 0.45 % / 20 % Topical OintmentPSNf9dfb2d7-4684-4525-994e-1e0ff90413d98
1998442menthol 0.1 % / zinc oxide 20 % Topical OintmentPSNf9dfb2d7-4684-4525-994e-1e0ff90413d98
884804menthol 0.45 % / zinc oxide 20 % Topical OintmentPSNf9dfb2d7-4684-4525-994e-1e0ff90413d98
2730301menthol 0.0045 MG/MG / zinc oxide 0.2 MG/MG Topical Ointment [Chamosyn]SBDf9dfb2d7-4684-4525-994e-1e0ff90413d98
1998442menthol 0.001 MG/MG / zinc oxide 0.2 MG/MG Topical OintmentSCDf9dfb2d7-4684-4525-994e-1e0ff90413d98
884804menthol 0.0045 MG/MG / zinc oxide 0.2 MG/MG Topical OintmentSCDf9dfb2d7-4684-4525-994e-1e0ff90413d98
2730301Chamosyn (menthol 0.45 % / zinc oxide 20 % ) Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98
1998442Menthol 0.001 MG/MG / ZNO 0.2 MG/MG Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98
884804Menthol 0.0045 MG/MG / ZNO 0.2 MG/MG Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98
2730301menthol 0.0045 MG/MG / ZNO 0.2 MG/MG Topical Ointment [Chamosyn]SYf9dfb2d7-4684-4525-994e-1e0ff90413d98
1998442menthol 0.1 % / zinc oxide 20 % Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98
884804menthol 0.45 % / zinc oxide 20 % Topical OintmentSYf9dfb2d7-4684-4525-994e-1e0ff90413d98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51028-003-0051028000300144 PACKET in 1 BOX (51028-003-00) / 5 g in 1 PACKET144 packet2016-01-010000-00-00NoNoCurrent
51028-003-0151028000301113 g in 1 TUBE (51028-003-01) 113 g2016-01-010000-00-00NoNoCurrent