FDA.reportPublic FDA data

TENSION HEADACHE RELIEF

Product NDC
68210-4108
Requested package NDC
68210-4108-5
11-digit product format
682104108
Labeler code
68210
Product ID
68210-4108_eecacd64-4f97-6122-e053-2a95a90af7e7
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN AND CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-08-05
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CAFFEINE
Active strength
500 mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-410868210-4108-5IInactivated by FDA2026-10-15

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
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product 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
68210-4108-1TENSION HEADACHE RELIEF100 in 1 BOTTLETABLET1009
68210-4108-2TENSION HEADACHE RELIEF200 in 1 BOTTLETABLET2009
68210-4108-5TENSION HEADACHE RELIEF150 in 1 BOTTLETABLET1509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4108TENSION HEADACHE RELIEF (ACETAMINOPHEN AND CAFFEINE) TABLET [SPIRIT PHARMACEUTICALS LLC]9Legacy NDC, 3 package rows20250101_adbe510b-83dd-4d0e-a8d0-33b9dfc981e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSNadbe510b-83dd-4d0e-a8d0-33b9dfc981e19
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCDadbe510b-83dd-4d0e-a8d0-33b9dfc981e19
307686APAP 500 MG / Caffeine 65 MG Oral TabletSYadbe510b-83dd-4d0e-a8d0-33b9dfc981e19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4108-568210410805150 TABLET in 1 BOTTLE (68210-4108-5) 150 tablet2020-10-220000-00-00NoNoCurrent