TUMS ULTRA - Haleon US Holdings LLC

Manufacturer
Haleon US Holdings LLC
Effective date
2026-09-29
Label type
HUMAN OTC DRUG LABEL
Version
21
Source
daily-update
Hydrated at
2026-10-01 14:01:12

Label at a glance#

ProductTUMS ULTRA
Active ingredientCALCIUM CARBONATE
Label structure18 sections

Indications and uses

relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms

Dosage and administration

adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor. Chew or crush tablets completely before swallowing. do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Label contents#

Full prescribing information#

Active ingredient (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 1000 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

  • do not take more than 7 tablets in 24 hours
  • if pregnant do not take more than 5 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and over:chew 2-3 tablets as symptoms occur, or as directed by a doctor. Chew or crush tablets completely before swallowing.
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains:elemental calcium 410 mg, magnesium 5 mg, sodium 2mg
  • store below 30 oC (86 oF) 

Other information– (Tropical Fruit and Assorted Fruit)

SPL UNCLASSIFIED SECTION

  • each tablet contains:elemental calcium 410 mg, magnesium 5 mg, sodium 2mg
  • store below 30 oC (86 oF) 
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive ingredients (Assorted Fruit)

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

Inactive ingredients (Assorted Tropical Fruit)

INACTIVE INGREDIENT SECTION

corn starch, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

Inactive ingredients (Assorted Berry)

INACTIVE INGREDIENT SECTION

adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

Inactive ingredient (Peppermint)

INACTIVE INGREDIENT SECTION

corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc

Inactive ingredients (Peppermint Tri-Color)

INACTIVE INGREDIENT SECTION

corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, flavor, mineral oil, sodium polyphosphate, sucrose, talc

Questions?

OTC - QUESTIONS SECTION

1-800-897-7535

Safety sealed- Do not use if printed inner seal beneath cap is missing or broken.

Gluten-Free

Principal Display Panel – Assorted Fruit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Assorted Fruit

72CHEWABLE TABLETS

ULTRASTRENGTH 1000

PAREVE

Tums Ultra Assorted Fruit 72 ct
Tums Ultra Assorted Fruit 72 ct

Principal Display Panel – Tropical Fruit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Tropical Fruit

72CHEWABLE TABLETS

ULTRASTRENGTH 1000

PAREVE

Tums Ultra Tropical Fruit 72 ct
Tums Ultra Tropical Fruit 72 ct

Principal Display Panel – Assorted Berries

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Assorted Berries

72CHEWABLE TABLETS

ULTRASTRENGTH 1000

PAREVE

Tums Ultra Assorted Berries 72ct
Tums Ultra Assorted Berries 72ct

Principal Display Panel - Peppermint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Peppermint

72CHEWABLE TABLETS

ULTRASTRENGTH 1000

PAREVE

Tums Ultra Peppermint 72 ct
Tums Ultra Peppermint 72 ct

Principal Display Panel – Peppermint (Tricolor)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0540-01

TUMS®

ANTACID

CALICUM CARBONATE

PEPPERMINT

ULTRASTRENGTH 1000

86CHEWABLE TABLETS

20% MORE FREE

PAREVE

Tums Ultra tricolor Peppermint 86 ct label
Tums Ultra tricolor Peppermint 86 ct label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0118-012020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0118-012020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0118-042020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0118-042020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0118-042020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0118-142020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0118-142020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0118-142020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0118-832020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0118-832020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0180-012020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0180-022020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0180-142020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0180-142020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0180-142020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0181-142020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0181-142020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0181-142020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0540-012020-12-01C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0118-012020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0118-042020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0180-142020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0180-142020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0181-012020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0181-032020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0181-032020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0181-032020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0181-052020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0181-052020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0181-052020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0181-062020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0228-042020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0228-052020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0228-052020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0228-062020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0228-062020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0228-072020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0228-072020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0228-072020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
0135-0540-012020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts
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0135-0540-012020-01-31C16284748780-19d75b9d0-c409-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0118-14EA - Each0135-01183d0991dd-9f20-433e-aa93-31df56aa722212012-07-24
0135-0118-83EA - Each0135-0118e2521c49-36c7-4f8a-bbf7-901df37a496b12012-07-24
0135-0180-02EA - Each0135-0180f3eb7a95-a3e4-4077-8350-ef2c0ed4a7d312013-07-02
0135-0180-14EA - Each0135-0180e7b09ab3-f105-47d2-9018-84220658039412012-07-24
0135-0181-01EA - Each0135-01813ca8e9eb-8f24-49a3-aa76-d454a879203612013-02-13
0135-0181-02EA - Each0135-01816118ebcd-49f3-4bc0-9d3c-97038cfba83b12013-07-02
0135-0181-03EA - Each0135-01811ab8b6e7-f1d8-4a9a-b3a1-dcfabacecf5d12012-07-24
0135-0181-05EA - Each0135-01815a64400c-be72-4160-b361-3cb94d44934912012-07-24
0135-0181-07EA - Each0135-0181b64d8086-5e12-4121-957f-0eb3a2f33a3312025-05-14
0135-0181-14EA - Each0135-018153c3be7d-8bc7-43e1-9b06-d3f7f5d491eb12012-07-24
0135-0228-01EA - Each0135-0228b819a5e3-083f-471a-b418-9ff6b34a7a9e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK9
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB9
ADIPIC ACIDINACTIVE INGREDIENT76A0JE0FKJ9
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69339
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA9
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A89
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP9
SODIUM POLYMETAPHOSPHATEINACTIVE INGREDIENTP1BM4ZH95L9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ9
SUCROSEINACTIVE INGREDIENTC151H8M5549
TALCINACTIVE INGREDIENT7SEV7J4R1U9

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
202026-07-07weekly-update2026-07-17 21:43:45
192025-05-22full-release2026-06-01 01:01:31

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 15 · 858 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SUSPENSION / ORAL1 mg/5mlExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route
572 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, CHEWABLE / ORAL4.5 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, CHEWABLE / ORAL40 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route
572 equally ranked IID candidates
ADIPIC ACIDADIPIC ACID76A0JE0FKJINSERT / VAGINAL171 mgExact identifier — unii candidate
52 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route
572 equally ranked IID candidates
SODIUM POLYMETAPHOSPHATESODIUM POLYMETAPHOSPHATEP1BM4ZH95LSUSPENSION / ORAL1 mg/1mlExact identifier — unii+route
26 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii+route
572 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route
572 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
26 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
SODIUM POLYMETAPHOSPHATESODIUM POLYMETAPHOSPHATEP1BM4ZH95LSUSPENSION / ORAL1 mg/1mlExact identifier — unii+route
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, CHEWABLE / ORAL4.5 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route
572 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
572 equally ranked IID candidates
ADIPIC ACIDADIPIC ACID76A0JE0FKJINSERT / VAGINAL171 mgExact identifier — unii candidate
52 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii+route
572 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route
572 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
572 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, CHEWABLE / ORAL4.5 mgExact identifier — unii+route+dosage form
26 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5607f6ca-b124-ff93-e063-6394a90a6de3f4786707-a0f7-4ba8-9656-06278d1b4b6c2026-07-07WarningsExact identifier
spl set id: f4786707-a0f7-4ba8-9656-06278d1b4b6c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.