Over-the-counter drug · OTC MONOGRAPH DRUG
Sleep Aid (Diphenhydramine hcl 25 mg) NDC 69168-263
Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · Allegiant Health
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69168-263Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0263Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-263-30 | 6916802633069168026330 | 30 TABLET in 1 BOTTLE (69168-263-30)Marketed from Mar 3, 2015 | |
| 69168-263-54 | 6916802635469168026354 | 1 BAG in 1 CARTON (69168-263-54) / 16458 TABLET in 1 BAGMarketed from May 8, 2025 | |
| 69168-263-93 | 6916802639369168026393 | 24 TABLET in 1 BOX (69168-263-93)Marketed from Mar 3, 2015 | |
| 69168-263-98 | 6916802639869168026398 | 200 TABLET in 1 BOTTLE (69168-263-98)Marketed from Jul 23, 2021 |
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)
- Sleep Aid
- Generic name (nonproprietary)
- diphenhydramine hcl 25 mg
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Allegiant HealthNDC labeler code 69168
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69168-263_b9e7a97b-a3e9-427c-8cc5-9c94941409a1SPL ID b9e7a97b-a3e9-427c-8cc5-9c94941409a1SPL set ID dbbc535f-515a-4d9b-b799-34e60f5230bbRxCUI 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
N469168026330followed by a unit qualifier and the quantityPackage 69168-0263-30. 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 relief of occasional sleeplessness
Excerpt only. Read the full label for complete information.
About NDC 69168-263
- What is NDC 69168-263?
- 69168-263 is the product NDC for Sleep Aid (diphenhydramine hcl 25 mg), Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Allegiant Health. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sleep Aid (Diphenhydramine HCl 25 mg).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sleep Aid?
- 58 other product NDCs are listed under this name. See all 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 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) |
|---|---|---|---|---|---|
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Amazon.com Services LLC | 72288-432 | 72288-0432-01 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0075 | 83059-0075-08 |
| Sleep Aidaconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, ignatia amara, kali phosphoricum, passiflora incarnata, phosphorus, pulsatilla, and valeriana officinalis. | Aconitum napellus whole 10 [hp_X]/59mL + 15 more ingredients | LiquidOral | King Bio Inc. | 57955-9986 | 57955-9986-02 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | Walgreens | 0363-9236 | 00363-9236-50 |
| Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Chewable gelOral | WALMART INC. (see also Equate) | 79903-426 | 79903-0426-24 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | TARGET Corporation | 82442-530 | 82442-0530-3282442-0530-60 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | CapsuleOral | WALGREENS | 0363-6130 | 00363-6130-2400363-6130-48 |
| Sleep Aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-368 | 51316-0368-22 |
| sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Publix Super Markets Inc | 56062-441 | 56062-0441-01 |
| sleep aiddoxylamine succinate | Doxylamine succinate 25 mg/1 | TabletOral | Walgreen Company | 0363-3462 | 00363-3462-80 |
Other NDCs under M 012
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 |
|---|---|---|---|---|
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | WALGREENS | 0363-0100 |
| CVS Health No Dripnasal mist | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | CVS PHARMACY,INC. | 69842-815 |
| Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | The Procter & Gamble Manufacturing Company | 69423-986 |
| Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | Lidl US LLC | 71141-180 |
| basic care tussin dm maxdextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Amazon.com Services LLC | 72288-293 |
| Menthol Cough Drops Honey Vanilla Flavormenthol | Menthol 2.5 mg/1 | LozengeOral | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 83698-013 |
| equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride | — | Kit | Sixarp, LLC | 59368-459 |
| Nasal Decongestant Maximum Strengthpseudoephedrine hcl | Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Better Living Brands, LLC | 21130-112 |
| Medicated Chest Rubcamphor, menthol, eucalyptus oil | Camphor (Synthetic) 4.8 g/100g + 2 more ingredients | CreamTopical | Jell Pharmaceuticals Pvt Ltd. | 30400-701 |
| equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-459 |
| NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-044 |
| Childrens Dye Free Allergydiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | P & L Development, LLC | 49580-0293 |
| Discount Drug Mart Original Nasaloxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-715 |
| Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Family Dollar Services Inc | 55319-705 |
| DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Dolgencorp Inc | 55910-928 |
| Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | LiquidOral | Haleon US Holdings LLC | 0031-8751 |
| Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride | — | KitNasal | Bayer HealthCare LLC. | 11523-0147 |
| Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | TabletOral | Selder, S.A. de C.V. | 63654-605 |
| Nasal Spray, 1oz, 24/7 Life by 7-Elevenoxymetazoline hcl nasal solution 0.05% | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | Lil' Drug Store Products, Inc. | 66715-5526 |
| Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-982 |
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