FDA.reportPublic FDA data

Unishield Pain Ache

Product NDC
49314-8218
11-digit product format
493148218
Labeler code
49314
Product ID
49314-8218_e7a2b4f5-a0ef-741c-e053-2995a90af8e7
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unishield
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-09-26
Marketing end
0000-00-00
Substance
ASPIRIN; CAFFEINE
Active strength
500 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
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 productproduct49314-8218IInactivated by FDA2026-10-12
excluded packagepackage49314-821849314-8218-0IInactivated by FDA2026-10-12

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
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
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
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49314-8218-0Unishield Pain Ache40 in 1 BOXTABLET, FILM COATED403
49314-8218-0Unishield Pain Ache2 in 1 PACKETTABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49314-8218UNISHIELD PAIN ACHE (ASPIRIN, CAFFEINE) TABLET, FILM COATED [UNISHIELD]3Legacy NDC, 2 package rows20240118_e7137224-88fd-0bc4-e053-2a95a90a9313.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702316aspirin 500 MG / caffeine 32.5 MG Oral TabletPSNe7137224-88fd-0bc4-e053-2a95a90a93133
702316aspirin 500 MG / caffeine 32.5 MG Oral TabletSCDe7137224-88fd-0bc4-e053-2a95a90a93133
702316ASA 500 MG / Caffeine 32.5 MG Oral TabletSYe7137224-88fd-0bc4-e053-2a95a90a93133

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49314-8218-04931482180040 PACKET in 1 BOX (49314-8218-0) > 2 TABLET, FILM COATED in 1 PACKET40 packet2022-09-260000-00-00NoNoCurrent