Gemma Cut the Cramp

Product NDC
75920-0465
11-digit product format
759200465
Labeler code
75920
Product ID
75920-0465_471b4be3-b0d3-b56e-e063-6394a90aaa59
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin, Caffeine
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Rally Labs LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-23
Substance
ASPIRIN; CAFFEINE
Active strength
500; 60 mg/1000mg; mg/1000mg
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
Gemma Cut the Cramp
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN500 mg/1000mg
CAFFEINE60 mg/1000mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E, 3G6A5W338E
Rxcui1537019

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
75920-0465-2Gemma Cut the Cramp6816 mg in 1 POUCHTABLET, EFFERVESCENT68163
75920-0465-2Gemma Cut the Cramp20 in 1 CARTONTABLET, EFFERVESCENT203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75920-0465GEMMA CUT THE CRAMP (ASPIRIN, CAFFEINE) TABLET, EFFERVESCENT [RALLY LABS LLC]2Current NDC, 2 package rows20241218_16c9a296-077a-8e12-e063-6294a90a1b8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1537019aspirin 500 MG / caffeine 60 MG Effervescent Oral TabletPSN16c9a296-077a-8e12-e063-6294a90a1b8b3
1537019aspirin 500 MG / caffeine 60 MG Effervescent Oral TabletSCD16c9a296-077a-8e12-e063-6294a90a1b8b3
1537019ASA 500 MG / Caffeine 60 MG Effervescent Oral TabletSY16c9a296-077a-8e12-e063-6294a90a1b8b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75920-0465-27592004650220 POUCH in 1 CARTON (75920-0465-2) / 6816 mg in 1 POUCH20 pouch2024-04-23NoNoHistorical