Benadryl
- Product NDC
- 29485-7963
- 11-digit product format
- 294857963
- Labeler code
- 29485
- Product ID
- 29485-7963_e3b61c1f-5412-5e33-e053-2995a90a0f61
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mechanical Servants, LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2015-10-19
- Marketing end
- 0000-00-00
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| calcium phosphate, dibasic, anhydrous | INACTIVE INGREDIENT | L11K75P92J | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| Carnauba Wax | INACTIVE INGREDIENT | R12CBM0EIZ | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| D&C red no. 27 | INACTIVE INGREDIENT | 2LRS185U6K | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [MECHANICAL SERVANTS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29485-7963 | BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.] | 14 | Legacy NDC | 20231207_53de0882-12ad-4c5c-bdb8-85d40d1da5e6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 29485-7963-2 | 29485796302 | 25 POUCH in 1 BOX (29485-7963-2) > 2 TABLET, FILM COATED in 1 POUCH | 25 pouch | 2020-07-10 | 0000-00-00 | No | No | Current |
| 29485-7963-3 | 29485796303 | 30 POUCH in 1 BOX (29485-7963-3) > 2 TABLET, FILM COATED in 1 POUCH | 30 pouch | 2015-10-19 | 0000-00-00 | No | No | Current |