What is NDC 53209-1002?

53209-1002 is the product NDC for Tylenol PM Extra Strength, Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Morning Star OTC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Tylenol PM Extra Strength (Acetaminophen and diphenhydramine hydrochloride).

What is the active ingredient?

Acetaminophen, Diphenhydramine hydrochloride.

Morning Star OTC, NDC labeler code 53209. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tylenol PM Extra Strength?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tylenol PM Extra Strength NDC 53209-1002

NDC codes

FDA NDC Directory

Product NDC (as listed)53209-1002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53209-1002Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
53209-1002-2	5320910020253209100202	25 BLISTER PACK in 1 POUCH (53209-1002-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1002-1)Marketed from Jun 19, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Tylenol PM Extra StrengthSuffix: Extra Strength
Generic name (nonproprietary): acetaminophen and diphenhydramine hydrochloride
Active ingredients: Acetaminophen — 500 mg/1Diphenhydramine hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Morning Star OTCNDC labeler code 53209
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 013
Marketing start: Jun 19, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 53209-1002_37e8f74e-9c3f-b0e7-e063-6394a90a5106SPL ID 37e8f74e-9c3f-b0e7-e063-6394a90a5106SPL set ID 6cd07a01-7034-4994-bbd3-bedcdf7d5b83RxCUI 1092189, 1092378UNII 362O9ITL9D, 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

N453209100202 followed by a unit qualifier and the quantity

Package 53209-1002-02. 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 Jun 19, 2025.

Indications (excerpt from the label)

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53209-1002

What is NDC 53209-1002?: 53209-1002 is the product NDC for Tylenol PM Extra Strength, Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Morning Star OTC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tylenol PM Extra Strength (Acetaminophen and diphenhydramine hydrochloride).
What is the active ingredient?: Acetaminophen, Diphenhydramine hydrochloride.
Who is the labeler?: Morning Star OTC, NDC labeler code 53209. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tylenol PM Extra Strength?: 5 other product NDCs are listed under this name. See all Tylenol PM Extra Strength NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tylenol PM Extra Strength NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochloride	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Navajo Manufacturing Company Inc.	67751-241	67751-0241-0167751-0241-02
Tylenol PM Extra Strengthacetaminophen	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	R J General Corporation	70264-028	70264-0028-01
Tylenol PM Extra Strengthacetaminophen, diphenhydramine hydrochloride	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Jones Healthcare Group - Packaging Services, Inc	67414-608	67414-0608-0067414-0608-06
Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochloride	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Kenvue Brands LLC	50580-608	50580-0608-0150580-0608-0250580-0608-03+5 more
Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochloride	Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Select Consumer Group	85237-2945	85237-2945-0185237-2945-0285237-2945-03+3 more

Other NDCs under M 013

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 013
Product	Strength	Form · route	Labeler	Product NDC
Acetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	COSTCO WHOLESALE CORPORATION	63981-019
Extra Strength Pain Releifacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Strategic Sourcing Services, LLC	70677-1242
Aspirin 81 mgaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	H E B	37808-600
TYLENOL Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Tablet, Film coatedOral	Morning Star OTC	53209-1001
Extra Strength Pain Relieveracetaminophen tablets 500 mg	Acetaminophen 500 mg/1	TabletOral	WALGREENS	0363-0669
Pain Relieveracetaminophen capsules 500mg (minis-red opaque)	Acetaminophen 500 mg/1	Capsule, Liquid filledOral	Walgreens	0363-6684
Mommys Bliss Childrens Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Mom Enterprises, LLC.	71444-793
Childrens Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	CVS Pharmacy	59779-126
Good Neighbor Pharmacy childrens pain and feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Amerisource Bergen	46122-211
Acetaminophen	Acetaminophen 160 mg/5mL	LiquidOral	A-S Medication Solutions	50090-6059
Members Mark Acetaminophenacetaminophen	Acetaminophen 500 mg/1	TabletOral	Sam's West Inc	68196-606
Mommys Bliss Infants Pain and Feveracetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Mom Enterprises, LLC.	71444-893
Thompson Extra Strength Non-Aspirinacetaminophen	Acetaminophen 500 mg/1	TabletOral	Thompson	73408-174
Aspirin 81 mg Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	CHAIN DRUG MARKETING ASSOCIATION, INC.	83324-089
Acetaminophen	Acetaminophen 500 mg/1	TabletOral	ASCLEMED USA INC.	87063-222
Pain Relief Aspirin Low Doseaspirin	Aspirin 81 mg/1	Tablet, Delayed releaseOral	Rite Aid Corporation	11822-0600
equate pain and fever childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Wal-Mart Stores Inc	49035-042
Pain and Fever Childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	P & L Development, LLC	49580-0282
Dye Free Pain and Fever Childrensacetaminophen	Acetaminophen 160 mg/5mL	SuspensionOral	Walgreens	0363-0285
Pain Reliever Extra Strengthacetaminophen	Acetaminophen 500 mg/1	Tablet, CoatedOral	Walgreen Company	0363-0519

Showing 20 of 40.