FDA.reportPublic FDA data

Menstrual Relief

Product NDC
41163-390
11-digit product format
411630390
Labeler code
41163
Product ID
41163-390_da8ef6bd-f366-46ae-a736-7000f0726f3b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine and Pyrilamine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-04-29
Marketing end
2027-02-28
Substance
ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Active strength
500; 60; 15 mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Menstrual Relief
Brand name suffix
Maximum Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE60 mg/1
PYRILAMINE MALEATE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 3G6A5W338E, R35D29L3ZA
Rxcui1597298

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
41163-390-10Menstrual ReliefMaximum Strength40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4018
41163-390-10Menstrual ReliefMaximum Strength1 in 1 CARTONTABLET, FILM COATED118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-390-10EA - Each41163-390ed1a4ecf-f440-4cb0-aeeb-4db225defee312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
CAFFEINEACTIVE INGREDIENT3G6A5W338EMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZAMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
CAFFEINEACTIVE MOIETY3G6A5W338EMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
PYRILAMINEACTIVE MOIETYHPE317O9TLMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673MENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [SUPERVALU INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-390MENSTRUAL RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]17Current NDC, Legacy NDC, 2 package rows20250109_807598ef-9f03-48df-b076-3ee95ef4b06c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN807598ef-9f03-48df-b076-3ee95ef4b06c18
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD807598ef-9f03-48df-b076-3ee95ef4b06c18
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY807598ef-9f03-48df-b076-3ee95ef4b06c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41163-390-10411630390101 BOTTLE, PLASTIC in 1 CARTON (41163-390-10) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2002-04-292027-02-28NoNoCurrent