FDA.reportPublic FDA data

Pain Relief Rapid Release Gelcaps

Product NDC
21130-270
11-digit product format
211300270
Labeler code
21130
Product ID
21130-270_458b7783-a98c-6f8a-e063-6394a90a9c44
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Safeway
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-05
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief Rapid Release Gelcaps
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-270-01Pain Relief Rapid Release GelcapsExtra Strength1 in 1 CARTONTABLET, COATED14
21130-270-01Pain Relief Rapid Release GelcapsExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED244
21130-270-13Pain Relief Rapid Release GelcapsExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED2254

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-270PAIN RELIEF RAPID RELEASE GELCAPS EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]3Current NDC, Legacy NDC, 3 package rows20241204_c830d1ac-c4c5-4eb1-98bb-22707cb6db91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc830d1ac-c4c5-4eb1-98bb-22707cb6db914
198440acetaminophen 500 MG Oral TabletSCDc830d1ac-c4c5-4eb1-98bb-22707cb6db914
198440APAP 500 MG Oral TabletSYc830d1ac-c4c5-4eb1-98bb-22707cb6db914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-270-01211300270011 BOTTLE, PLASTIC in 1 CARTON (21130-270-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2015-08-050000-00-00NoNoCurrent
21130-270-1321130027013225 TABLET, COATED in 1 BOTTLE, PLASTIC (21130-270-13) 2018-04-170000-00-00NoNoCurrent