Pepcid Complete
- Product NDC
- 16837-891
- 11-digit product format
- 168370891
- Labeler code
- 16837
- Product ID
- 16837-891_4ce25a0c-d535-15d7-e063-6294a90a25f7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- famotidine, calcium carbonate, and magnesium hydroxide
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA020958
- Marketing category
- NDA
- Marketing start
- 2009-03-01
- Substance
- CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
- Active strength
- 800; 10; 165 mg/1; mg/1; mg/1
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pepcid Complete
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCIUM CARBONATE | 800 mg/1 |
| FAMOTIDINE | 10 mg/1 |
| MAGNESIUM HYDROXIDE | 165 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H0G9379FGK, 5QZO15J2Z8, NBZ3QY004S |
| Rxcui | 283641, 688892 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16837-891-25 | Pepcid Complete | 25 in 1 BOTTLE | TABLET, CHEWABLE | 25 | | 19 |
| 16837-891-50 | Pepcid Complete | 50 in 1 BOTTLE | TABLET, CHEWABLE | 50 | | 19 |
| 16837-891-65 | Pepcid Complete | 25 in 1 BOTTLE | TABLET, CHEWABLE | 25 | | 19 |
| 16837-891-66 | Pepcid Complete | 50 in 1 BOTTLE | TABLET, CHEWABLE | 50 | | 19 |
| 16837-891-70 | Pepcid Complete | 70 in 1 BOTTLE | TABLET, CHEWABLE | 70 | | 19 |
| 16837-891-72 | Pepcid Complete | 72 in 1 BOTTLE | TABLET, CHEWABLE | 72 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| calcium carbonate | ACTIVE INGREDIENT | H0G9379FGK | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| famotidine | ACTIVE INGREDIENT | 5QZO15J2Z8 | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| magnesium hydroxide | ACTIVE INGREDIENT | NBZ3QY004S | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| carbonate ion | ACTIVE MOIETY | 7UJQ5OPE7D | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| famotidine | ACTIVE MOIETY | 5QZO15J2Z8 | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| hydroxide ion | ACTIVE MOIETY | 9159UV381P | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| acacia | INACTIVE INGREDIENT | 5C5403N26O | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| cellulose acetate | INACTIVE INGREDIENT | 3J2P07GVB6 | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| D&C yellow no. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| Dextrose | INACTIVE INGREDIENT | IY9XDZ35W2 | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| FD&C blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| hydroxypropyl cellulose (Type E) | INACTIVE INGREDIENT | 66O7AQV0RT | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
| sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16837-891 | PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC] | 16 | Current NDC, Legacy NDC, 6 package rows | 20241114_a2ef8424-7d80-42b0-a01e-f378f629b2b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16837-891-25 | 16837089125 | 25 TABLET, CHEWABLE in 1 BOTTLE (16837-891-25) | 2009-03-01 | 0000-00-00 | No | No | Current |
| 16837-891-50 | 16837089150 | 50 TABLET, CHEWABLE in 1 BOTTLE (16837-891-50) | 2009-03-01 | 0000-00-00 | No | No | Current |
| 16837-891-65 | 16837089165 | 25 TABLET, CHEWABLE in 1 BOTTLE (16837-891-65) | 2024-01-11 | | No | No | Current |
| 16837-891-66 | 16837089166 | 50 TABLET, CHEWABLE in 1 BOTTLE (16837-891-66) | 2023-12-14 | | No | No | Current |
| 16837-891-70 | 16837089170 | 70 TABLET, CHEWABLE in 1 BOTTLE (16837-891-70) | 2025-08-29 | | No | No | Current |
| 16837-891-72 | 16837089172 | 72 TABLET, CHEWABLE in 1 BOTTLE (16837-891-72) | 2026-05-29 | | 0 | | Current |