Over-the-counter drug · OTC MONOGRAPH DRUG
good sense nighttime sleep aid (Diphenhydramine hydrochloride) NDC 0113-0431
Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · L. Perrigo Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0113-0431-62 | 0011304316200113043162 | 12 BLISTER PACK in 1 CARTON (0113-0431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 25, 2001 | |
| 0113-0431-78 | 0011304317800113043178 | 1 BOTTLE in 1 CARTON (0113-0431-78) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 29, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- good sense nighttime sleep aid
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- L. Perrigo CompanyNDC labeler code 0113
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 010
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0113-0431_70250c98-1eb2-4522-bdc6-7ce5a1468fdaSPL ID 70250c98-1eb2-4522-bdc6-7ce5a1468fdaSPL set ID ba2adc30-0301-4d53-bce6-fc8b7e34b076RxCUI 1049630UNII TC2D6JAD40
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400113043162followed by a unit qualifier and the quantityPackage 00113-0431-62. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use for relief of occasional sleeplessness
Excerpt only. Read the full label for complete information.
About NDC 0113-0431
- What is NDC 0113-0431?
- 0113-0431 is the product NDC for good sense nighttime sleep aid (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by L. Perrigo Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- good sense nighttime sleep aid (Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for good sense nighttime sleep aid?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 010
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophen | Diphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mL | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-985 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | BJWC (Berkley & Jensen / BJ's) | 68391-793 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-736 |
| Diphenhydramine HCl 25mgsleep aid | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Allegiant Health | 69168-002 |
| berkley and jensen sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | BJWC | 68391-186 |
| AXIV - VroZzzdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Vivunt Pharma LLC | 82706-014 |
| Revasol Sleep Aiddiphenhydramine hcl | Diphenhydramine HCl 50 mg/30mL | LiquidOral | Rnv LLC | 84379-284 |
| Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophen | Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 | Tablet, CoatedOral | The Procter & Gamble Manufacturing Company | 37000-974 |
| Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-860 |
| Sleep Tabsdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-4274 |
| Nightime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | BETTER LIVING BRANDS LLC. | 21130-711 |
| Diphenhydramine HCl | Diphenhydramine HCl 50 mg/30mL | LiquidOral | BI-MART | 37835-519 |
| Sleep Aid NightTimediphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-672 |
| Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-916 |
| Nighttime Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | BIONPHARMA INC. | 69452-427 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-091 |
| Sleep Aid | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Better Living Brands LLC | 21130-052 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-894 |
| Quality Choice Nighttime Sleep-Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Chain Drug Marketing Association, Inc. | 63868-970 |
| Nighttime Sleep Aiddiphenhydramine hcl 50mg | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Grocery Outlet | 85828-410 |
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