FDA.reportPublic FDA data

Rapid Repair Healing Cream

Product NDC
65278-110
11-digit product format
652780110
Labeler code
65278
Product ID
65278-110_4bba33c0-e465-fe3e-e063-6394a90aadfb
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin, Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
June Jacobs Labs LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-11-09
Substance
ALLANTOIN; DIMETHICONE
Active strength
.9907; 2.9721 g/198.14g; g/198.14g
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
Rapid Repair Healing Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.9907 g/198.14g
DIMETHICONE2.9721 g/198.14g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
186c13be-5e41-b9c9-e063-6294a90ad574Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65278-110-01Rapid Repair Healing Cream198.14 g in 1 TUBECREAM198.142
65278-110-02Rapid Repair Healing Cream198.14 g in 1 CARTONCREAM198.142
65278-110-03Rapid Repair Healing Cream112.38 g in 1 TUBECREAM112.382
65278-110-04Rapid Repair Healing Cream112.38 g in 1 CARTONCREAM112.382
65278-110-05Rapid Repair Healing Cream47.32 g in 1 TUBECREAM47.322
65278-110-06Rapid Repair Healing Cream47.32 g in 1 CARTONCREAM47.322

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65278-110RAPID REPAIR HEALING CREAM (ALLANTOIN, DIMETHICONE) CREAM [JUNE JACOBS LABS LLC]1Current NDC, 6 package rows20240523_186c13be-5e41-b9c9-e063-6294a90ad574.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 57 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PETROLEUMWHITE PETROLATUMVIVE HEALTH LLC24ae3875-1c86-c7ba-e063-6394a90a67292024-10-17WarningsExact identifier
application number: M016
Meijer Skin Relieving MoisturizingDIMETHICONEMEIJER DISTRIBUTION, INC8e5be6b3-87e7-d958-e053-2a95a90a69612024-10-16WarningsExact identifier
application number: M016
GenRx Daily Defense Skin RepairingDIMETHICONEPureTek Corporation7d2827fd-b40f-454b-bb60-54d77823b18c2024-10-16WarningsExact identifier
application number: M016
Equate Daily Moisturizing Dimethicone Skin ProtectantDIMETHICONEWalmart Stores Inc.8fda01f7-a52a-4a63-98ac-b32cb47947f32024-10-16WarningsExact identifier
application number: M016
Hill Country EssentialsDIMETHICONEH.E.Bc51d8647-8af6-473a-b989-dfa6bfdc368d2024-10-15WarningsExact identifier
application number: M016
UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTEDWHITE PETROLEUMUniversal Distribution Center LLC649e571f-0cd6-41e4-b31f-c818f94fb01d2024-10-15WarningsExact identifier
application number: M016
WALGREENS ECZEMACOLLOIDAL OATMEALWALGREEN COMPANYfc502963-4cb6-5ce5-e053-6394a90a58c32024-10-14WarningsExact identifier
application number: M016
Target Up and Up Daily MoisturizingDIMETHICONETARGET CORPORATIONf118e0eb-1e66-50ab-e053-2995a90a2cb92024-10-14WarningsExact identifier
application number: M016
Target Up and Up Petroleum JellyWHITE PETROLATUMTARGET CORPORATIONbaeaf660-ac4f-1ebc-e053-2995a90ac0c12024-10-14WarningsExact identifier
application number: M016
Target Up and Up Healing Petrolatum Skin ProtectantPETROLATUMTARGET CORPORATIONf9b62cd9-94ec-26b4-e053-6394a90a82672024-10-14WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCc1b10d34-2905-4ad6-8f90-7f9800de2b462024-10-14WarningsExact identifier
application number: M016
Gentle STEPS vitamins A and D Diaper Rash and Skin ProtectantLANOLIN, PETROLATUMOld East Main CO.1d20d040-ed6c-4ce9-81a9-3bbf2fa4587d2024-10-11WarningsExact identifier
application number: M016
McKesson Skin ProtectantZINC OXIDEMcKesson Medical-Surgical Inc.50b2709d-aab1-42d8-8ebd-bfd2e1ac6a7b2024-10-11WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LPe1089e9a-ecaa-5c65-e053-2995a90a86992024-10-10WarningsExact identifier
application number: M016
Attitude Diaper Cream Zinc UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)00283894-ddc6-0faa-e063-6394a90ae47c2024-10-02WarningsExact identifier
application number: M016
DermacinRx Zinc Oxide Skin HealingZINC OXIDEPureTek Corporation541b8da8-f0c1-4f57-94a7-193084d9a6112024-10-02WarningsExact identifier
application number: M016
DimopairDIMETHICONEPureTek Corporationdc16af56-b97d-c17f-e053-2995a90a55a02024-10-01WarningsExact identifier
application number: M016
Skin Repair ComplexDIMETHICONEPureTek Corporation1c3059c5-5f7e-264e-e054-00144ff8d46c2024-10-01WarningsExact identifier
application number: M016
Barrier Build Skin Protectant CreamCOLLOIDAL OATMEALILIA, Inc.231d41b8-2a56-6eb8-e063-6394a90ac64f2024-09-27WarningsExact identifier
application number: M016
insect bite relief 01MENTHOLCosmuses Cosmetics (Ningbo) Co., Ltd.229ee3a7-4129-7b59-e063-6394a90a6f402024-09-23WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65278-110-0165278011001198.14 g in 1 TUBE (65278-110-01) 198.14 g2011-11-09NoNoCurrent
65278-110-0265278011002198.14 g in 1 CARTON (65278-110-02) 198.14 g2011-11-09NoNoCurrent
65278-110-0365278011003112.38 g in 1 TUBE (65278-110-03) 112.38 g2011-11-09NoNoCurrent
65278-110-0465278011004112.38 g in 1 CARTON (65278-110-04) 112.38 g2011-11-09NoNoCurrent
65278-110-056527801100547.32 g in 1 TUBE (65278-110-05) 47.32 g2011-11-09NoNoCurrent
65278-110-066527801100647.32 g in 1 CARTON (65278-110-06) 47.32 g2011-11-09NoNoCurrent