FDA.reportPublic FDA data

Pharbest Regular Strength Aspirin

Product NDC
16103-365
Requested package NDC
16103-365-11
11-digit product format
161030365
Labeler code
16103
Product ID
16103-365_1b710869-90ca-4656-a0f3-ee524dea884f
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-01-12
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage16103-36516103-365-11IInactivated by FDA2026-10-15

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 · 8 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
16103-365-082026-01-29Drug Facts
16103-365-112026-01-29Drug Facts
16103-365-082024-12-31Drug Facts
16103-365-112024-12-31Drug Facts
16103-365-082023-01-30Drug Facts
16103-365-112023-01-30Drug Facts
16103-365-082021-03-30Drug Facts
16103-365-112021-03-30Drug Facts
16103-365-082020-01-31Drug Facts
16103-365-112020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-365-08Pharbest Regular Strength Aspirin1 in 1 CARTONTABLET13
16103-365-08Pharbest Regular Strength Aspirin100 in 1 BOTTLETABLET1003
16103-365-11Pharbest Regular Strength Aspirin1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-365-08EA - Each16103-3659f2370eb-aebc-4721-a732-66e203de0fa712014-11-05
16103-365-11EA - Each16103-365da77b868-13a4-4286-b7b7-0fa0e1805eef12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EPHARBEST REGULAR STRENGTH ASPIRIN (ASPIRIN) TABLET [A-S MEDICATION SOLUTIONS LLC]1
ASPIRINACTIVE INGREDIENTR16CO5Y76EPHARBEST REGULAR STRENGTH ASPIRIN (ASPIRIN) TABLET [PHARBEST PHARMACEUTICALS, INC]1
ASPIRINACTIVE MOIETYR16CO5Y76EPHARBEST REGULAR STRENGTH ASPIRIN (ASPIRIN) TABLET [A-S MEDICATION SOLUTIONS LLC]1
ASPIRINACTIVE MOIETYR16CO5Y76EPHARBEST REGULAR STRENGTH ASPIRIN (ASPIRIN) TABLET [PHARBEST PHARMACEUTICALS, INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHARBEST REGULAR STRENGTH ASPIRIN (ASPIRIN) TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHARBEST REGULAR STRENGTH ASPIRIN (ASPIRIN) TABLET [PHARBEST PHARMACEUTICALS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-365PHARBEST REGULAR STRENGTH ASPIRIN (ASPIRIN) TABLET [PHARBEST PHARMACEUTICALS, INC]3Legacy NDC, 3 package rows20250101_6403dd67-4e37-4928-8505-2be590247408.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSN6403dd67-4e37-4928-8505-2be5902474083
212033aspirin 325 MG Oral TabletSCD6403dd67-4e37-4928-8505-2be5902474083
212033ASA 325 MG Oral TabletSY6403dd67-4e37-4928-8505-2be5902474083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16103-365-11161030365111000 TABLET in 1 BOTTLE (16103-365-11) 1000 tablet2007-01-120000-00-00NoNoCurrent