FDA.reportPublic FDA data

NOTTS - Tension Headache

Product NDC
82706-010
11-digit product format
827060010
Labeler code
82706
Product ID
82706-010_0aeeedc8-dcb9-087d-e063-6394a90ad1f5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
VIVUNT PHARMA LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-30
Substance
ACETAMINOPHEN; CAFFEINE
Active strength
500; 65 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
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
NOTTS - Tension Headache
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307686Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
08f2ae03-967b-ad7e-e063-6294a90a8484Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-010-01NOTTS - Tension Headache24 in 1 BOTTLE, PLASTICTABLET244
82706-010-01NOTTS - Tension Headache1 in 1 CARTONTABLET14
82706-010-02NOTTS - Tension Headache1 in 1 CARTONTABLET14
82706-010-02NOTTS - Tension Headache100 in 1 BOTTLE, PLASTICTABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-010NOTTS - TENSION HEADACHE (ACETAMINOPHEN, CAFFEINE) TABLET [VIVUNT PHARMA LLC]4Current NDC, 4 package rows20231125_08f2ae03-967b-ad7e-e063-6294a90a8484.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 23 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINHYVEE INC3e602287-565e-a5b9-e063-6294a90abc172026-01-13WarningsExact identifier
application number: M013
ASPIRIN DELAYED RELEASE 81MGASPIRIN DELAYED RELEASE 81MGFarmacias De Similares TX LLC3a8a3efc-f0b3-411c-e063-6394a90a84b72026-01-13WarningsExact identifier
application number: M013
Chewable Aspirin 81 mgASPIRINHYVEE INC459f749f-9d23-8752-e063-6394a90a8c812026-01-13WarningsExact identifier
application number: M013
ASPIRIN 325 mgASPIRINHYVEE INC459d01df-6ff6-cff6-e063-6394a90ab35c2026-01-13WarningsExact identifier
application number: M013
Pain Terminator Extra Strength Pain ReliefCAFFEINE, ACETAMINOPHEN, ASPIRINWildman Business Group8ffb02d9-92df-4d2f-a367-1c71490807fb2026-01-12WarningsExact identifier
application number: M013
Aspirin PacksASPIRINSina Health Inc2865a2c3-53fc-ab9a-e063-6394a90a14182026-01-12WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.64696f65-415e-4ce1-a5b3-70662fbcb0022026-01-12WarningsExact identifier
application number: M013
Aspirin enteric coated low doseASPIRINWalgreen Company186a6270-e3de-4499-88a4-5f723fee3e342026-01-12WarningsExact identifier
application number: M013
Tension HeadacheACETAMINOPHEN, CAFFEINECardinal Health 110, LLC. DBA Leader96684e3f-a13e-49c3-b437-d2627e528a2d2026-01-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINFamily Dollar Services Incd35d798e-76f1-454d-86f6-ad11c3bf17d82026-01-12WarningsExact identifier
application number: M013
Xpect AcetaminophenACETAMINOPHENCintas Corporationf4aed854-730e-493d-b523-122156e08dde2026-01-09WarningsExact identifier
application number: M013
AspirinASPIRININVAHEALTH INCe5e8a8d5-9174-7975-e053-2a95a90a9aa62026-01-08WarningsExact identifier
application number: M013
Xpect Cold ReliefACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCLCintas Corporation02391d55-32b2-4083-9315-98e9b3650c552026-01-08WarningsExact identifier
application number: M013
pain relief back and body EXTRA STRENGTHASPIRIN, CAFFEINERite Aid Corporationa71392c8-3f5b-4d00-baba-a4055ed68bc12026-01-07WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.8fed703a-9de2-4c76-a783-fcf004f9b8902026-01-07WarningsExact identifier
application number: M013
AspirinASPIRINAmerisource Bergenc3099892-a8cd-4574-a6f9-041e59e2feae2026-01-07WarningsExact identifier
application number: M013
Bactimicina Childrens Pain and FeverACETAMINOPHENDLC Laboratories, Inc.bdade270-d813-4178-b594-4951632b68392026-01-07WarningsExact identifier
application number: M013
Goodmeds Extra Strength Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.02c60967-46d7-49b7-82be-bc3c5fd364842026-01-06WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEa73f8217-9eae-4e2a-b29c-7de3861d0e372026-01-06WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporationf77f0120-4042-4b11-ba9c-cd35e1cd0bee2026-01-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN08f2ae03-967b-ad7e-e063-6294a90a84844
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD08f2ae03-967b-ad7e-e063-6294a90a84844
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY08f2ae03-967b-ad7e-e063-6294a90a84844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82706-010-01827060010011 BOTTLE, PLASTIC in 1 CARTON (82706-010-01) / 24 TABLET in 1 BOTTLE, PLASTIC2023-10-30NoNoCurrent
82706-010-02827060010021 BOTTLE, PLASTIC in 1 CARTON (82706-010-02) / 100 TABLET in 1 BOTTLE, PLASTIC2023-10-30NoNoCurrent