FDA.reportPublic FDA data

GeriGard

Product NDC
69771-050
11-digit product format
697710050
Labeler code
69771
Product ID
69771-050_42297230-d3d0-3f77-e063-6294a90ab140
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Geri-Gentle Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-07
Substance
ZINC OXIDE
Active strength
18 mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
GeriGard
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE18 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044412Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05b67830-adc8-46b1-b0a0-a6cd2875e80cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-01-30GeriGard
2024-01-30GeriGard
2023-11-10GeriGard
2023-11-10GeriGard
2023-07-28GeriGard
2023-07-28GeriGard

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-050-04GeriGard24 in 1 CASEOINTMENT2412
69771-050-04GeriGard113 g in 1 TUBEOINTMENT11312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-050GERIGARD (ZINC OXIDE) OINTMENT [GERI-GENTLE CORPORATION]10Current NDC, Legacy NDC, 2 package rows20240718_05b67830-adc8-46b1-b0a0-a6cd2875e80c.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 50 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Shea Butter Petroleum JellyPETROLATUM JELLYWalgreense35d913e-2195-4e3d-ae38-f010317140fd2024-12-17WarningsExact identifier
application number: M016
Jell Pharmaceuticals Vitamin A DPETROLATUMJell Pharmaceuticals Pvt. Ltd.6ab8ba54-3679-4fd0-a876-cb89aace96ca2024-12-17WarningsExact identifier
application number: M016
Shea Butter Petroleum JellyPETROLATUM JELLYJell Pharmaceuticals Pvt. Ltd.cd848f33-e863-d3af-e053-2a95a90a45b12024-12-17WarningsExact identifier
application number: M016
Softlips Cherry, Raspberry, VanillaDIMETHICONEThe Mentholatum Companyb7b2f64e-27b4-4c71-95cf-78b37540f9752024-12-17WarningsExact identifier
application number: M016
Softlips Tropical CoconutDIMETHICONEThe Mentholatum Company1203ea70-dc1a-4439-a230-bd3fc45f75f52024-12-17WarningsExact identifier
application number: M016
Softlips Tropical Coconut Peach PassionDIMETHICONEThe Mentholatum Company11f619e7-4a58-45e4-8f4a-fe358832ab642024-12-17WarningsExact identifier
application number: M016
Softlips Watermelon, Tropical Coconut, Peach PassionDIMETHICONEThe Mentholatum Companye9212502-909a-4184-905e-f31a53602c3b2024-12-17WarningsExact identifier
application number: M016
Softlips WatermelonDIMETHICONEThe Mentholatum Companye32d738e-e0af-4f17-a753-bdc7938b16842024-12-17WarningsExact identifier
application number: M016
Softlips Peach PassionDIMETHICONEThe Mentholatum Company4a133e73-e51b-4f04-91de-dc8c4d4dba302024-12-17WarningsExact identifier
application number: M016
Sweet Cheeks DiaperZINC OXIDETubby Todd4ed0afe1-c893-453e-b4d5-f32561360ec12024-12-17WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMGeri-care Pharmaceutials Corpfd76c101-a287-f92c-e053-6294a90a44682024-12-17WarningsExact identifier
application number: M016
Foster and Thrive Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC298171e1-2826-d33b-e063-6394a90a875a2024-12-17WarningsExact identifier
application number: M016
Secura Dimethicone ProtectantDIMETHICONESmith & Nephew Medical Ltd83f92ac9-4114-4192-926d-be2854a841062024-12-16WarningsExact identifier
application number: M016
CVS Maximum Strength Anti-Itch CreamHYDROCORTISONE 1%CVS Healthc2876cba-d7e7-de5c-e053-2a95a90a63552024-12-16WarningsExact identifier
application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip)DIMETHICONE, OCTINOXATE, OCTISALATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc4121d671-521c-4f36-b2db-652c13f730c62024-12-16WarningsExact identifier
application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm)DIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c2024-12-16WarningsExact identifier
application number: M016
Balmex Diaper RashZINC OXIDE 11.3%Randob Labs, LTDf7f7a89d-d4e0-9faa-e053-6294a90aaf7b2024-12-15WarningsExact identifier
application number: M016
QC ScarALLANTOIN 0.5%CDMAf7e3d751-a47a-2bca-e053-6394a90a65412024-12-15WarningsExact identifier
application number: M016
Dr. Butler Soothing IncontinencePETROLATUM 36%Beyond Health P.A.d17a0c28-a5b7-4df0-e053-2995a90a8edd2024-12-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044412zinc oxide 1.8 % Topical OintmentPSN05b67830-adc8-46b1-b0a0-a6cd2875e80c12
1044412zinc oxide 0.018 MG/MG Topical OintmentSCD05b67830-adc8-46b1-b0a0-a6cd2875e80c12
1044412zinc oxide 1.8 % Topical OintmentSY05b67830-adc8-46b1-b0a0-a6cd2875e80c12
1044412ZNO 0.018 MG/MG Topical OintmentSY05b67830-adc8-46b1-b0a0-a6cd2875e80c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69771-050-046977100500424 TUBE in 1 CASE (69771-050-04) / 113 g in 1 TUBE24 tube2018-08-070000-00-00NoNoCurrent