FDA.reportPublic FDA data

BioBarrier Renewal Cream

Product NDC
72203-019
11-digit product format
722030019
Labeler code
72203
Product ID
72203-019_222d037c-6c17-07ee-e063-6394a90a496d
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
CREAM
Route
TOPICAL
Labeler
bluemercury
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-22
Substance
ALLANTOIN
Active strength
7.5 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
BioBarrier Renewal Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN7.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ee15f84-0561-3cd2-e063-6394a90ab68eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72203-019-01BioBarrier Renewal Cream50 g in 1 TUBECREAM502
72203-019-02BioBarrier Renewal Cream1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72203-019BIOBARRIER RENEWAL CREAM (ALLANTOIN) CREAM [BLUEMERCURY]2Current NDC, 2 package rows20240918_1ee15f84-0561-3cd2-e063-6394a90ab68e.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 26 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMATITIS FACE BALMCOLLOIDAL OATMEALSkinfix, Inc.86d2db7d-f1d4-4bca-aba4-d4c96b83c1a62026-01-08WarningsExact identifier
application number: M016
First Aid Beauty Dry Skin Rescue Kit 5x Hydration PowerCOLLOIDAL OATMEALJCS Global Distribution, Inc.47d06283-21cd-4a69-e063-6294a90adb052026-01-07WarningsExact identifier
application number: M016
DE LA CRUZ DIAPER RASHALLANTOIN, PETROLATUM, AND ZINC OXIDEDLC Laboratories, Inc.5949aa0f-a7cb-453c-81fd-9fa24653a4522026-01-07WarningsExact identifier
application number: M016
Thera Wise Natural HemorrhoidalWITCH HAZELDerma Wise Skin Care Ltd.a29fb680-cfc8-4a7b-9970-563fa0e2bed62026-01-06WarningsExact identifier
application number: M016
Sky and Sol SPF25 Lip BalmSKY AND SOL SPF25 LIP BALMGuangzhou Fantesy Biotechnology Co.,Ltd1f37c0c3-6443-60a3-e063-6394a90a596f2026-01-05WarningsExact identifier
application number: M016
Remedy EssentialsWHITE PETROLATUM,ZINC OXIDEMedline Industries, LP42a033d6-782b-2d7f-e054-00144ff8d46c2026-01-05WarningsExact identifier
application number: M016
BUNUSS Estriol FaceESTRIOLJiashen International Trade Limited478b5690-038a-ba1c-e063-6394a90a3ad62026-01-04WarningsExact identifier
application number: M016
Skin Protectant for Babies and kidsSKIN PROTECTANT OINTMENTNeilmed Pharmaceuticals Inc.448b70db-ca81-db7b-e063-6294a90a5f0d2026-01-02WarningsExact identifier
application number: M016
Puriya Eczema CreamCOLLOIDAL OATMEALIPC Republic, Inc.24ac044e-13fa-5ff6-e063-6294a90a99852026-01-01WarningsExact identifier
application number: M016
ScarzenDIMETHICONEVillage Pharma LLC1550f4e5-22e2-491f-8184-de65da7234e62026-01-01WarningsExact identifier
application number: M016
NUVALU 100 PURE PETROLEUMWHITE PETROLATUMJC SALES48f74b99-7ead-b0d0-e063-6394a90a49292026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMJC SALES48f79c2a-b314-169f-e063-6294a90a576e2026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMJC SALES490ac0a6-eac0-a74f-e063-6394a90a84ed2026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM COCOA BUTTERWHITE PETROLATUMJC SALES490af001-c78c-e2d2-e063-6394a90abdb02026-01-01WarningsExact identifier
application number: M016
NUVALU 100 PURE PETROLEUMWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.4946ac1a-f475-fbb1-e063-6394a90a30bc2026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.4946d1b7-ae1b-1e73-e063-6394a90a1ed22026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.49471d77-303a-8536-e063-6394a90aea512026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM COCOA BUTTERWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.49472319-09d1-7c4f-e063-6294a90a26a72026-01-01WarningsExact identifier
application number: M016
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1fa6282a-172e-f5c8-e063-6294a90a4fb12025-12-31WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla LatteCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company27713ae6-b428-e0d7-e063-6394a90a7a892025-12-31WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72203-019-017220300190150 g in 1 TUBE50 gHistorical
72203-019-02722030019021 TUBE in 1 BOX (72203-019-02) / 50 g in 1 TUBE (72203-019-01) 1 tube2024-05-22NoNoCurrent