Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Sleep Aid (Diphenhydramine hcl) NDC 41163-367
Diphenhydramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · United Natural Foods, Inc. dba UNFI
NDC codes
FDA NDC DirectoryProduct NDC (as listed)41163-367Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41163-0367Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41163-367-06 | 41163036706 | 1 BOTTLE, PLASTIC in 1 CARTON (41163-367-06) / 200 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Jun 10, 2000 | |
| 41163-367-08 | 41163036708 | 2 BLISTER PACK in 1 CARTON (41163-367-08) / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 10, 2000 | |
| 41163-367-12 | 41163036712 | 1 BOTTLE, PLASTIC in 1 CARTON (41163-367-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Jun 10, 2000 |
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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- United Natural Foods, Inc. dba UNFINDC labeler code 41163
- 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 41163-367_5cc14fb2-96e1-4f98-a848-81504336f370SPL ID 5cc14fb2-96e1-4f98-a848-81504336f370SPL set ID 6c9b7576-428a-4884-8331-bb312c9046bdRxCUI 1049630UNII TC2D6JAD40UPC 0041163428539
- 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
N441163036706followed by a unit qualifier and the quantityPackage 41163-0367-06. 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)
Uses for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Excerpt only. Read the full label for complete information.
About NDC 41163-367
- What is NDC 41163-367?
- 41163-367 is the product NDC for Nighttime Sleep Aid (diphenhydramine hcl), Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by United Natural Foods, Inc. dba UNFI. It has 3 package NDCs, 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?
- United Natural Foods, Inc. dba UNFI, NDC labeler code 41163. 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?
- 75 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 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 |
|---|---|---|---|---|
| ADWE dye-free childrens allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SyrupOral | RARITAN PHARMACEUTICALS INC | 68163-710 |
| Allergy Relief 25 mgdiphenhydramine hcl 25mg | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | Ulai Health LLC | 73057-348 |
| AXIV - VroZzzdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Vivunt Pharma LLC | 82706-014 |
| basic care nighttime sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Amazon.com Services LLC | 72288-186 |
| berkley and jensen sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | BJWC | 68391-186 |
| Best Choice Childrens Allergy Relief Bubblegum flavordiphenhydramine hcl | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 63941-710 |
| Betr sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Live Betr LLC | 80267-431 |
| Calmco Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/5mL | SolutionOral | CalmCo LLC | 73282-2525 |
| CalmCo Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | CalmCo LLC | 73282-2527 |
| CalmCo Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | CalmCo LLC | 73282-2528 |
| CalmCo Sleep Aid Gummy Bitediphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Bar, ChewableOral | CalmCo LLC | 73282-2518 |
| careone nighttime sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-431 |
| CVS Childrens Nighttime Multi Symptom Coldacetaminophen , diphenhydramine hydrochloride,phenylephrine hydrochloride | Acetaminophen 325 mg/10mL + 2 more ingredients | LiquidOral | CVS PHARMACY | 51316-733 |
| CVS Health Nighttime Sleep-Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS Pharmacy,Inc. | 59779-893 |
| CVS Nighttime Childrens Cold and Cough Multi-Symptom Reliefchlorpheniramine maleate and dextromethorphan hydrobromide | Chlorpheniramine maleate 2 mg/15mL; Dextromethorphan hydrobromide 15 mg/15mL | SolutionOral | CVS PHARMACY | 51316-752 |
| CVS NightTime Coldacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride | Acetaminophen 650 mg/30mL + 3 more ingredients | SolutionOral | CVS PHARMACY | 51316-641 |
| CVS Nighttime Cold and Flu Reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | CVS PHARMACY | 51316-692 |
| CVS Nighttime Sleep Aiddiphenhydramine hydrochloride and acetaminophen | Acetaminophen 1000 mg/30mL; Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | CVS PHARMACY | 69842-448 |
| dg health sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Dolgencorp, LLC | 55910-186 |
| dg health sleep aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Dolgencorp Inc | 55910-431 |
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