Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Sleep-Aid (Diphenhydramine hcl) NDC 53041-633
Diphenhydramine hydrochloride 50 mg/30mL · Liquid · Oral · Guardian Drug Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53041-633-58 | 5304106335853041063358 | 177 mL in 1 BOTTLE (53041-633-58)Marketed from Jan 11, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Nighttime Sleep-Aid
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 50 mg/30mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Guardian Drug CompanyNDC labeler code 53041
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication part338
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 53041-633_329d343f-2056-4870-930c-348917bfb2bcSPL ID 329d343f-2056-4870-930c-348917bfb2bcSPL set ID 329d343f-2056-4870-930c-348917bfb2bcRxCUI 1248354UNII 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
N453041063358followed by a unit qualifier and the quantityPackage 53041-0633-58. 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(S) for relief of occasional sleeplessness helps you to fall asleep if you have difficulty falling asleep
Excerpt only. Read the full label for complete information.
About NDC 53041-633
- What is NDC 53041-633?
- 53041-633 is the product NDC for Nighttime Sleep-Aid (diphenhydramine hcl), Diphenhydramine hydrochloride 50 mg/30mL liquid, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nighttime Sleep-Aid (Diphenhydramine HCl).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Guardian Drug Company, NDC labeler code 53041. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nighttime Sleep-Aid?
- 74 other product NDCs are listed under this name. See all Nighttime Sleep-Aid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nighttime Sleep-Aid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Kroger | 41226-793 | 41226-0793-02 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0073 | 83059-0073-08 |
| nighttime sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Amazon.com Services LLC | 72288-765 | 72288-0765-40 |
| Nighttime Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Grocery Outlet | 85828-439 | 85828-0439-38 |
| Nighttime Sleep Aiddiphenhydramine hcl 50mg | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Grocery Outlet | 85828-410 | 85828-0410-38 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Grocery Outlet, Inc. | 85828-793 | 85828-0793-01 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0122 | — |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | BJWC (Berkley & Jensen / BJ's) | 68391-613 | 68391-0613-92 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | BJWC (Berkley & Jensen / BJ's) | 68391-793 | 68391-0793-09 |
| Nighttime Sleep Aid | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Allegiant Health | 69168-486 | 69168-0486-39 |
Other NDCs under part338
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 |
|---|---|---|---|---|
| Nighttime Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Chain Drug Marketing Association Inc. | 83324-015 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Velocity Pharma LLC | 76168-015 |