FDA.reportPublic FDA data

Stanback

Product NDC
63029-501
11-digit product format
630290501
Labeler code
63029
Product ID
63029-501_c7af9f6c-018c-4612-b0a6-ba2e90fbec37
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin and Caffeine
Dosage form
POWDER
Route
ORAL
Labeler
Medtech Products Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-01
Substance
ASPIRIN; CAFFEINE
Active strength
845; 65 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stanback
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN845 mg/1
CAFFEINE65 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E, 3G6A5W338E
Rxcui994435, 1053327

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-501-012020-04-23C16284748780-19d75b9cf-d2bc-f424-e053-dadaa90a57ceStanback
63029-501-022020-04-23C16284748780-19d75b9cf-d2bc-f424-e053-dadaa90a57ceStanback
63029-501-062020-04-23C16284748780-19d75b9cf-d2bc-f424-e053-dadaa90a57ceStanback
63029-501-242020-04-23C16284748780-19d75b9cf-d2bc-f424-e053-dadaa90a57ceStanback
63029-501-012020-01-31C16284748780-19d75b9cf-d2bc-f424-e053-dadaa90a57ceStanback
63029-501-022020-01-31C16284748780-19d75b9cf-d2bc-f424-e053-dadaa90a57ceStanback
63029-501-062020-01-31C16284748780-19d75b9cf-d2bc-f424-e053-dadaa90a57ceStanback
63029-501-242020-01-31C16284748780-19d75b9cf-d2bc-f424-e053-dadaa90a57ceStanback

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-501-01Stanback50 in 1 CARTONPOWDER5012
63029-501-02Stanback2 in 1 PACKAGEPOWDER212
63029-501-06Stanback6 in 1 PACKAGEPOWDER612
63029-501-24Stanback24 in 1 CARTONPOWDER2412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-501-01EA - Each63029-5011a6a8f40-6b56-4858-b452-bcdc4963344a12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76ESTANBACK (ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]1
CAFFEINEACTIVE INGREDIENT3G6A5W338ESTANBACK (ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76ESTANBACK (ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]1
CAFFEINEACTIVE MOIETY3G6A5W338ESTANBACK (ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0STANBACK (ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]1
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131STANBACK (ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSTANBACK (ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10STANBACK (ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-501STANBACK (ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]12Current NDC, Legacy NDC, 4 package rows20250116_caaa1313-09e4-45aa-8836-346f6a370196.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994435aspirin 845 MG / caffeine 65 MG Oral PowderPSNcaaa1313-09e4-45aa-8836-346f6a37019612
1053327STANBACK Headache Powder 845 MG / 65 MG Oral Powder, Reformulated Jan 2011PSNcaaa1313-09e4-45aa-8836-346f6a37019612
1053327aspirin 845 MG / caffeine 65 MG Oral Powder [Stanback Headache Powder Reformulated Jan 2011]SBDcaaa1313-09e4-45aa-8836-346f6a37019612
994435aspirin 845 MG / caffeine 65 MG Oral PowderSCDcaaa1313-09e4-45aa-8836-346f6a37019612
994435ASA 845 MG / Caffeine 65 MG Oral PowderSYcaaa1313-09e4-45aa-8836-346f6a37019612
1053327ASA 845 MG / Caffeine 65 MG Oral Powder [Stanback Headache Powder Reformulated Jan 2011]SYcaaa1313-09e4-45aa-8836-346f6a37019612
1053327Stanback Headache Powder Reformulated Jan 2011 (ASA 845 MG / caffeine 65 MG) Oral PowderSYcaaa1313-09e4-45aa-8836-346f6a37019612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-501-016302905010150 POWDER in 1 CARTON (63029-501-01) 50 powder2012-10-010000-00-00NoNoCurrent
63029-501-02630290501022 POWDER in 1 PACKAGE (63029-501-02) 2 powder2012-10-010000-00-00NoNoCurrent
63029-501-06630290501066 POWDER in 1 PACKAGE (63029-501-06) 6 powder2012-10-010000-00-00NoNoCurrent
63029-501-246302905012424 POWDER in 1 CARTON (63029-501-24) 24 powder2012-06-010000-00-00NoNoCurrent