FDA.reportPublic FDA data

Goodys

Product NDC
63029-663
11-digit product format
630290663
Labeler code
63029
Product ID
63029-663_9f0c99e5-5c55-483d-9ce6-5f71ae2b405e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Aspirin and Caffeine
Dosage form
POWDER
Route
ORAL
Labeler
Medtech Products Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-01
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
325; 500; 65 mg/1; 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
2027-12-31
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
Goodys
Brand name suffix
Cool Orange Headache
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
ASPIRIN500 mg/1
CAFFEINE65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
R16CO5Y76EInternal 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
692836Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31212c97-9975-427e-bc3d-f7125f30299aAvailable 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
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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
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
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product 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
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63029-663-012020-04-10Goodys Cool Orange Headache Powder
63029-663-012020-04-10Goodys Cool Orange Headache Powder
63029-663-042020-04-10Goodys Cool Orange Headache Powder
63029-663-042020-04-10Goodys Cool Orange Headache Powder
63029-663-012020-01-31Goodys Cool Orange Headache Powder
63029-663-012020-01-31Goodys Cool Orange Headache Powder
63029-663-042020-01-31Goodys Cool Orange Headache Powder
63029-663-042020-01-31Goodys Cool Orange Headache Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-663-01GoodysCool Orange Headache24 in 1 BOXPOWDER247
63029-663-04GoodysCool Orange Headache4 in 1 BOXPOWDER47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-663-01EA - Each63029-66321b8b9c2-2b2e-459d-9ac9-4e374f91c9b012022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
ASPIRINACTIVE INGREDIENTR16CO5Y76EGOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
CAFFEINEACTIVE INGREDIENT3G6A5W338EGOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
ASPIRINACTIVE MOIETYR16CO5Y76EGOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
CAFFEINEACTIVE MOIETY3G6A5W338EGOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
GUAR GUMINACTIVE INGREDIENTE89I1637KEGOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AGOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4GOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]3
AcetaminophenACTIVE INGREDIENT362O9ITL9DGOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
AspirinACTIVE INGREDIENTR16CO5Y76EGOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
CaffeineACTIVE INGREDIENT3G6A5W338EGOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
AcetaminophenACTIVE MOIETY362O9ITL9DGOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
AspirinACTIVE MOIETYR16CO5Y76EGOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
CaffeineACTIVE MOIETY3G6A5W338EGOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UGOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
Guar GumINACTIVE INGREDIENTE89I1637KEGOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
MannitolINACTIVE INGREDIENT3OWL53L36AGOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4GOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4GOODYS COOL ORANGE (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [LIL' DRUG STORE PRODUCTS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-663GOODYS COOL ORANGE HEADACHE (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]6Current NDC, Legacy NDC, 2 package rows20241101_31212c97-9975-427e-bc3d-f7125f30299a.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 76 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENAurohealth LLC30756257-f748-4a5d-b031-dd267d0f91ad2023-11-29WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENAurohealth LLC8eda893f-5266-4b7a-95b9-2e194973cf062023-11-29WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENAurohealth LLC00ec6518-b5e3-49d1-a342-139381c3bfd22023-11-29WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEFACETAMINOPHENBetter Living Brands, LLCfadb4c09-071f-56c0-e053-6294a90ae6c12023-11-28WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEBetter Living Brands, LLCfc07d516-9ffe-9989-e053-6294a90ae1a52023-11-28WarningsExact identifier
application number: M013
NOTTS - Tension HeadacheACETAMINOPHEN, CAFFEINEVIVUNT PHARMA LLC08f2ae03-967b-ad7e-e063-6294a90a84842023-11-24WarningsExact identifier
application number: M013
Sanatos Multi Symptoms NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0a60326a-a17b-e843-e063-6394a90ac2112023-11-22WarningsExact identifier
application number: M013
Sanatos Nighttime Multi SymptomsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0ab188f3-f7f9-d665-e063-6294a90a198a2023-11-22WarningsExact identifier
application number: M013
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENA-S Medication Solutions400d4a29-9e39-4e74-8272-37be5d7899242023-11-22WarningsExact identifier
application number: M013
RIGHT REMEDIES Pain Relief Extra Strength CapletACETAMINOPHENStrive Pharmaceuticals Inc.dcce28d9-8528-489e-b995-1d98e9d0e6ad2023-11-21WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692836acetaminophen 325 MG / aspirin 500 MG / caffeine 65 MG Oral PowderPSN31212c97-9975-427e-bc3d-f7125f30299a7
692836acetaminophen 325 MG / aspirin 500 MG / caffeine 65 MG Oral PowderSCD31212c97-9975-427e-bc3d-f7125f30299a7
692836APAP 325 MG / ASA 500 MG / Caffeine 65 MG Oral PowderSY31212c97-9975-427e-bc3d-f7125f30299a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-663-016302906630124 POWDER in 1 BOX (63029-663-01) 24 powder2012-06-010000-00-00NoNoCurrent
63029-663-04630290663044 POWDER in 1 BOX (63029-663-04) 4 powder2012-06-010000-00-00NoNoCurrent