DELSYM

Product NDC
72854-352
11-digit product format
728540352
Labeler code
72854
Product ID
72854-352_7738b019-5d8a-4cff-be3f-2645e391306c
Type
HUMAN OTC DRUG
Nonproprietary name
camphor (natural), eucalyptus oil, and menthol, unspecified form
Dosage form
OINTMENT
Route
TOPICAL
Labeler
RB Health (US) LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-07-01
Marketing end
0000-00-00
Substance
CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM
Active strength
53 mg/g; mg/g; mg/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72854-352DDiscontinued by firm2026-10-15
excluded packagepackage72854-35272854-352-01DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct72854-352DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72854-35272854-352-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72854-352-01GM - Gram72854-352b77088f1-4980-4285-a94c-cbc46208c46b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72854-352DELSYM NO MESS VAPOR ROLL ON (CAMPHOR (NATURAL), EUCALYPTUS OIL, AND MENTHOL, UNSPECIFIED FORM) OINTMENT [RB HEALTH (US) LLC]2Legacy NDC20241225_b168516f-1d7e-4fbd-ab66-9525fdf0d086.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72854-352-01728540352011 CONTAINER in 1 CARTON (72854-352-01) > 50 g in 1 CONTAINER1 container2022-07-010000-00-00NoNoCurrent