OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Famotidine USP 10mg
Active Ingredients
Famotidine USP 10mg
Acid Reducer
Directions • adults and
children 12 years and over: • to relieve symptoms,
swallow 1 tablet with a glass of water. Do not chew.
• to prevent symptoms, swallow 1 tablet with a
glass of water 60 minutes before eating food or
drinking beverages that cause heartburn • do not
use more than 2 tablets in 24 hours • children under
12 years: ask a doctor
Uses: • relieves heartburn associated with acid
indigestion and sour stomach • prevents heartburn
associated with acid indigestion and sour stomach
brought on by eating or drinking certain food and
beverages
Warnings: Allergy alert: Do not use if
you are allergic to famotidine or other acid reducers
Do not use • if you have trouble or pain swallowing
food, vomiting with blood, or bloody or black stools.
These may be signs of a serious condition. See your
doctor. • with other acid reducers Ask a doctor
before use if you have • had heartburn over 3
months. This may be a sign of a more serious
condition. • heartburn with lightheadedness,
sweating, or dizziness • chest pain or shoulder
pain with shortness of breath; sweating; pain
spreading to arms, neck or shoulders; or
lightheadedness • frequent chest pain • frequent
wheezing particularly with heartburn • unexplained
weight loss • nausea or vomiting • stomach pain
Stop use and ask a doctor if • your
heartburn continues or worsens • you
need to take this product for more than
14 days
If pregnant or breast-feeding,
ask a health professional before use.
Keep
out of reach of children. In case of
overdose, get medical help or contact a Poison
Control Center right away.
Inactive ingredients hydroxypropyl
cellulose, hypromellose, iron oxide red, magnesium
stearate, microcrystalline cellulose, polyethylene
glycol 400, pregelatinized starch, talc, titanium
dioxide
MM1
| Class | Version | Type | Effective |
|---|---|---|---|
| FAMOTIDINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae | Product name | 7 | 20260317 |
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| cf645750-2e70-f6e1-c05a-a52847def5dd | Product name | 9 | 20250312 |
| 4fdc761c-585e-054b-8ebe-86130a26e4c1 | Product name | 2 | 20221205 |
| fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52904-448-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7b82-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52904-448-01 | Heartburn Relief | 1 in 1 PACKET | TABLET | 1 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| FAMOTIDINE | ACTIVE INGREDIENT | 5QZO15J2Z8 | 2 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52904-448 | 52904-448-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| TALC | 7SEV7J4R1U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FAMOTIDINE | 5QZO15J2Z8 | ACTIB |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CREAM / TOPICAL | 10 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, LIQUID FILLED / ORAL | 1122 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUPPOSITORY / RECTAL | 0.25 mg/mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LOTION / TOPICAL | 5 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION, SOLUTION / INTRAMUSCULAR | 20.3 %w/v | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAVENOUS | 28216 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE / ORAL | 13440 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUSPENSION / ORAL | 400 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SPONGE / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077146-001 | FAMOTIDINE | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077146-001 | FAMOTIDINE | 10MG | TABLET / ORAL | 2005-03-07 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a3f26a2a-f404-4d48-bbae-0ee263ff409b | ce584e98-5d52-4412-b18c-e623b4ae24d1 | 2014-04-14 | Warnings | a3f26a2a-f404-4d48-bbae-0ee263ff409b ce584e98-5d52-4412-b18c-e623b4ae24d1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.