FDA.reportPublic FDA data

BackAid

Product NDC
52389-153
11-digit product format
523890153
Labeler code
52389
Product ID
52389-153_32c0bf9d-154f-e502-e063-6294a90a0b35
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, pamabrom
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kobayashi Healthcare International, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-02-01
Substance
ACETAMINOPHEN; PAMABROM
Active strength
500; 25 mg/1; 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
BackAid
Brand name suffix
Max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
PAMABROM25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, UA8U0KJM72
Rxcui198449, 1356080

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-153-01BackAidMax14 in 1 BLISTER PACKTABLET, FILM COATED1414
52389-153-03BackAidMax38 in 1 BOTTLE, PLASTICTABLET, FILM COATED3814
52389-153-14BackAidMax1 in 1 CARTONTABLET, FILM COATED114
52389-153-28BackAidMax2 in 1 CARTONTABLET, FILM COATED214
52389-153-35BackAidMax5 in 1 CARTONTABLET, FILM COATED514
52389-153-35BackAidMax7 in 1 BLISTER PACKTABLET, FILM COATED714
52389-153-38BackAidMax1 in 1 CARTONTABLET, FILM COATED114
52389-153-46BackAidMax1 in 1 CARTONTABLET, FILM COATED114
52389-153-46BackAidMax46 in 1 BOTTLETABLET, FILM COATED4614

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
PamabromACTIVE INGREDIENTUA8U0KJM72BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
AcetaminophenACTIVE MOIETY362O9ITL9DBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
BROMOTHEOPHYLLINEACTIVE MOIETYFZG87K1MQ6BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Calcium sulfate dihydrateINACTIVE INGREDIENT4846Q921YMBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Magnesium oxideINACTIVE INGREDIENT3A3U0GI71GBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Magnesium silicateINACTIVE INGREDIENT9B9691B2N9BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Magnesium stearateINACTIVE INGREDIENT70097M6I30BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Mineral oilINACTIVE INGREDIENTT5L8T28FGPBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Polyethylene glycol 600INACTIVE INGREDIENTNL4J9F21N9BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Potassium gluconateINACTIVE INGREDIENT12H3K5QKN9BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
PovidoneINACTIVE INGREDIENTFZ989GH94EBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
SorbitolINACTIVE INGREDIENT506T60A25RBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Starch, cornINACTIVE INGREDIENTO8232NY3SJBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Stearic acidINACTIVE INGREDIENT4ELV7Z65APBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-153BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]14Current NDC, Legacy NDC, 9 package rows20250416_fb9a5647-b7c9-4820-b148-91060e34cb83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198449acetaminophen 500 MG / pamabrom 25 MG Oral TabletPSNfb9a5647-b7c9-4820-b148-91060e34cb8314
1356080BACKAID MAX EXTRA STRENGTH 500 MG / 25 MG 6HR Oral TabletPSNfb9a5647-b7c9-4820-b148-91060e34cb8314
1356080acetaminophen 500 MG / pamabrom 25 MG Oral Tablet [Backaid]SBDfb9a5647-b7c9-4820-b148-91060e34cb8314
198449acetaminophen 500 MG / pamabrom 25 MG Oral TabletSCDfb9a5647-b7c9-4820-b148-91060e34cb8314
198449APAP 500 MG / pamabrom 25 MG Oral TabletSYfb9a5647-b7c9-4820-b148-91060e34cb8314
1356080APAP 500 MG / pamabrom 25 MG Oral Tablet [Backaid]SYfb9a5647-b7c9-4820-b148-91060e34cb8314
1356080Backaid (acetaminophen 500 MG / pamabrom 25 mg) oral tabletSYfb9a5647-b7c9-4820-b148-91060e34cb8314
1356080Backaid (APAP 500 MG / pamabrom 25 mg) oral tabletSYfb9a5647-b7c9-4820-b148-91060e34cb8314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52389-153-015238901530114 in 1 BLISTER PACKHistorical
52389-153-035238901530338 in 1 BOTTLE, PLASTICHistorical
52389-153-14523890153141 BLISTER PACK in 1 CARTON (52389-153-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK (52389-153-01) 1 blister pack2011-06-010000-00-00NoNoCurrent
52389-153-28523890153282 BLISTER PACK in 1 CARTON (52389-153-28) / 14 TABLET, FILM COATED in 1 BLISTER PACK (52389-153-01) 2 blister pack2011-03-010000-00-00NoNoCurrent
52389-153-35523890153355 BLISTER PACK in 1 CARTON (52389-153-35) / 7 TABLET, FILM COATED in 1 BLISTER PACK5 blister pack2011-06-010000-00-00NoNoCurrent
52389-153-38523890153381 BOTTLE, PLASTIC in 1 CARTON (52389-153-38) / 38 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52389-153-03) 2010-09-010000-00-00NoNoCurrent
52389-153-46523890153461 BOTTLE in 1 CARTON (52389-153-46) / 46 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-04-290000-00-00NoNoCurrent