Over-the-counter drug · OTC MONOGRAPH DRUG
Pain Relief PM Extra Strength (Pain relief pm) NDC 69168-003
Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · Allegiant Health
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69168-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0003Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-003-50 | 69168000350 | 1 BOTTLE in 1 CARTON (69168-003-50) / 50 TABLET in 1 BOTTLEMarketed from Nov 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)
- Pain Relief PM Extra StrengthSuffix: Extra Strength
- Generic name (nonproprietary)
- pain relief pm
- Active ingredients
- Acetaminophen — 500 mg/1Diphenhydramine 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 013
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69168-003_d3d02f1a-47df-498e-871d-58e79640fe81SPL ID d3d02f1a-47df-498e-871d-58e79640fe81SPL set ID 4c9969be-a01f-4ca4-800a-e404229ce28bRxCUI 1092189UNII 362O9ITL9D, TC2D6JAD40UPC 0852510005781
- 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
N469168000350followed by a unit qualifier and the quantityPackage 69168-0003-50. 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) temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Excerpt only. Read the full label for complete information.
About NDC 69168-003
- What is NDC 69168-003?
- 69168-003 is the product NDC for Pain Relief PM Extra Strength (pain relief pm), Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Allegiant Health. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pain Relief PM Extra Strength (Pain Relief PM).
- What is the active ingredient?
- Acetaminophen, 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 Pain Relief PM Extra Strength?
- 12 other product NDCs are listed under this name. See all Pain Relief PM Extra Strength NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pain Relief PM Extra Strength products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-085 | 83324-0085-0183324-0085-50 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | MARC GLASSMAN, INC. | 68998-195 | 68998-0195-02 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | MARC GLASSMAN, INC. | 68998-071 | 68998-0071-03 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | GoodSense | 50804-825 | 50804-0825-02 |
| Pain Relief PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | QUALITY CHOICE (Chain Drug Marketing Association) | 63868-119 | 63868-0119-50 |
| Pain Relief PM Extra Strengthacetaminophen 500 mg and diphenhydramine hcl 25 mg | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Allegiant Health | 69168-393 | 69168-0393-0269168-0393-2469168-0393-26+2 more |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | HEB | 37808-795 | 37808-0795-03 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | TopCo Associates LLC | 36800-095 | 36800-0095-0336800-0095-17 |
| Pain Relief PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | H E B | 37808-556 | 37808-0556-0937808-0556-31 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | DOLGENCORP, LLC | 55910-655 | 55910-0655-1055910-0655-31 |
Other NDCs under M 013
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 |
|---|---|---|---|---|
| Calmour Childrens Acetaminophen Strips Chewableacetaminophen oral chewable 80 mg | Acetaminophen 80 mg/1 | StripOral | Calmour | 82918-006 |
| Acetaminophen and Diphenhydramine HCL | Diphenhydramine 25 mg/1; Acetaminophen 500 mg/1 | TabletOral | PUBLIX SUPERMARKETS, INC | 41415-661 |
| Clear Choice Regular Strength Pain Relieveracetaminophen | Acetaminophen 325 mg/1 | TabletOral | Athlete's Needs, Inc. | 53185-005 |
| Acetaminophen (Red)acetaminophen | Acetaminophen 325 mg/1 | Capsule, Liquid filledOral | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 53345-010 |
| Pain Relief PMacetaminophen, aspirin, diphenhydramine citrate | Acetaminophen 250 mg/1 + 2 more ingredients | Tablet, Film coatedOral | CVS Pharmacy | 59779-894 |
| Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | Marc Glassman, Inc. | 68998-525 |
| Children Acetaminophen Oral Solutionacetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | MAJOR PHARMACEUTICALS | 0904-7014 |
| signature care childrens pain reliefacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Safeway | 21130-243 |
| Aspirin 81mg Adult Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | TopCare | 36800-880 |
| Green Guard Maximum Strength Non-Aspirinacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-619 |
| Aspirin | Aspirin 325 mg/1 | Tablet, Delayed releaseOral | Amerisource Bergen | 46122-596 |
| Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-6928 |
| equate childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-959 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-298 |
| Pain Reliever PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Walgreen Company | 0363-0556 |
| Cafizetamol Forteacetaminophen, caffeine | Acetaminophen 500 mg/1; Caffeine 65 mg/1 | Tablet, Film coatedOral | OPMX LLC | 69729-147 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | PUBLIX SUPERMARKETS, INC | 41415-538 |
| Low Dose Aspirinaspirin | Aspirin 81 mg/1 | Tablet, CoatedOral | Hy-Vee | 42507-006 |
| Aspirin 81aspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Amerisource Bergen | 46122-598 |
| Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-6929 |
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