FDA.reportPublic FDA data

AQUAGARD

Product NDC
67777-014
Requested package NDC
67777-014-63
11-digit product format
677770014
Labeler code
67777
Product ID
67777-014_eec7c048-55f5-52b2-e053-2a95a90a95c5
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrating Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-12-20
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
41 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67777-01467777-014-63DDiscontinued by firm2026-09-14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-014-03GM - Gram67777-01441ace1dc-dd59-4d59-9238-3b91e07dcf5d12023-08-08
67777-014-04GM - Gram67777-014cf706574-a27c-4f7b-a632-dfee55e8325b12023-08-08
67777-014-05EA - Each67777-01493f916b8-c8c9-4039-9fd1-b31869d2537e12023-08-08
67777-014-63GM - Gram67777-014ca7162c1-bdc4-41f1-98aa-a9f07bc829bb12023-08-08
67777-014-64GM - Gram67777-014ce872799-0625-42de-a300-577b1d46a7da12023-08-08
67777-014-65EA - Each67777-014af79ff9d-25c6-4500-9984-48f47cffa22312023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-014AQUAGARD (HYDRATING OINTMENT) OINTMENT [DYNAREX CORPORATION]5Legacy NDC20241122_812b71ea-48ee-7e5e-e053-2a91aa0a7e57.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-014-636777700146324 TUBE in 1 CASE (67777-014-63) > 106 g in 1 TUBE (67777-014-03) 24 tube2019-12-200000-00-00NoNoCurrent