FDA.reportPublic FDA data

Maximum Strength PEPCID AC

Product NDC
16837-889
11-digit product format
168370889
Labeler code
16837
Product ID
16837-889_21af4ff4-5892-565e-e063-6394a90aa728
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA020325
Marketing category
NDA
Marketing start
2024-03-11
Substance
FAMOTIDINE
Active strength
20 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Maximum Strength PEPCID AC
Brand name suffix
Icy Cool Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui104094, 310273

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16837-889-20Maximum Strength PEPCID ACIcy Cool Mint1 in 1 CARTONTABLET, FILM COATED12
16837-889-20Maximum Strength PEPCID ACIcy Cool Mint20 in 1 BOTTLETABLET, FILM COATED202
16837-889-40Maximum Strength PEPCID ACIcy Cool Mint40 in 1 BOTTLETABLET, FILM COATED402
16837-889-40Maximum Strength PEPCID ACIcy Cool Mint1 in 1 CARTONTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16837-889MAXIMUM STRENGTH PEPCID AC ICY COOL MINT (FAMOTIDINE) TABLET, FILM COATED [KENVUE BRANDS LLC]2Current NDC, 4 package rows20241114_0f343092-4fc7-1fff-e063-6294a90aba6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN0f343092-4fc7-1fff-e063-6294a90aba6e2
104094Pepcid AC 20 MG Oral TabletPSN0f343092-4fc7-1fff-e063-6294a90aba6e2
104094famotidine 20 MG Oral Tablet [Pepcid]SBD0f343092-4fc7-1fff-e063-6294a90aba6e2
310273famotidine 20 MG Oral TabletSCD0f343092-4fc7-1fff-e063-6294a90aba6e2
104094Pepcid 20 MG Oral TabletSY0f343092-4fc7-1fff-e063-6294a90aba6e2
104094Pepcid AC 20 MG Oral TabletSY0f343092-4fc7-1fff-e063-6294a90aba6e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16837-889-20168370889201 BOTTLE in 1 CARTON (16837-889-20) / 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-11NoNoHistorical
16837-889-40168370889401 BOTTLE in 1 CARTON (16837-889-40) / 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-03-11NoNoHistorical