What is NDC 0067-0112?

0067-0112 is the product NDC for Theraflu Severe Cold Relief Nighttime Soft Chews, Acetaminophen 325 mg/1; Diphenhydramine hydrochloride 12.5 mg/1 tablet, chewable, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Theraflu Severe Cold Relief Nighttime Soft Chews (Acetaminophen, Diphenhydramine HCl).

What is the active ingredient?

Acetaminophen, Diphenhydramine hydrochloride.

Haleon US Holdings LLC, NDC labeler code 0067. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Theraflu Severe Cold Relief Nighttime Soft Chews?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 0067-0112

NDC codes

FDA NDC Directory

Product NDC (as listed)0067-0112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00067-0112Add 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
0067-0112-01	0006701120100067011201	20 TABLET, CHEWABLE in 1 BOTTLE (0067-0112-01)Marketed from Sep 30, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Theraflu Severe Cold Relief Nighttime Soft ChewsSuffix: Severe Cold Relief Nighttime Soft Chews
Generic name (nonproprietary): acetaminophen, diphenhydramine hcl
Active ingredients: Acetaminophen — 325 mg/1Diphenhydramine hydrochloride — 12.5 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: Haleon US Holdings LLCNDC labeler code 0067
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Sep 30, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 0067-0112_21636332-818b-26bf-e063-6394a90a1925SPL ID 21636332-818b-26bf-e063-6394a90a1925SPL set ID 6ba64bbe-7599-406a-9187-737c0f8c1c2aRxCUI 2691689UNII 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

N400067011201 followed by a unit qualifier and the quantity

Package 00067-0112-01. 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 Sep 5, 2024.

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to a cold: minor aches and pains sore throat pain headache runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0067-0112

What is NDC 0067-0112?: 0067-0112 is the product NDC for Theraflu Severe Cold Relief Nighttime Soft Chews, Acetaminophen 325 mg/1; Diphenhydramine hydrochloride 12.5 mg/1 tablet, chewable, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Theraflu Severe Cold Relief Nighttime Soft Chews (Acetaminophen, Diphenhydramine HCl).
What is the active ingredient?: Acetaminophen, Diphenhydramine hydrochloride.
Who is the labeler?: Haleon US Holdings LLC, NDC labeler code 0067. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Theraflu Severe Cold Relief Nighttime Soft Chews?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 012

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

FDA NDC Directory listings under M 012
Product	Strength	Form · route	Labeler	Product NDC
Cough Reliefdextromethorphan hydrobromide	Dextromethorphan hydrobromide 15 mg/1	Capsule, Liquid filledOral	Advanced Rx LLC	80513-311
TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr	—	Kit	TARGET CORPORATION	82442-559
Geri-Dryl allergy reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Tablet, CoatedOral	VerityRx	83939-0683
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci	—	Kit	TARGET Corporation	11673-420
Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide	Petrolatum 49 g/100g; Zinc oxide 15 g/100g	CreamTopical	Welmedix LLC	24330-410
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	Topco Associates LLC	36800-143
Allergy Childrensdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	H E B	37808-012
Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin	Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL	LiquidOral	H E B	37808-594
Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin	Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1	TabletOral	Strategic Sourcing Services LLC	49348-728
Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol	Menthol 8.3 mg/1	LozengeOral	Ricola Ag	54305-323
Discount drug mart Extra Moisturizingoxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	DISCOUNT DRUG MART	53943-720
Mucus Reliefguaifenesin	Guaifenesin 400 mg/1	TabletOral	Geri-Care Pharmaceuticals, Corp	57896-714
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl	Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL	LiquidOral	Haleon US Holdings LLC	0031-0101
Throat Comfort Orange Mint Cinnamon Dropsmenthol	Menthol 3.6 mg/1	LozengeOral	Ricola USA Inc.	63667-342
Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated	Guaifenesin 200 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Lil' Drug Store products, Inc.	66715-5632
COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 3 more ingredients	Capsule, Liquid filledOral	Walgreens	0363-9016
Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl	Acetaminophen 650 mg/20mL + 2 more ingredients	LiquidOral	Walgreens	0363-9130
Pyrilamine Maleate and Dextromethorphan Hydrobromide	Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL	LiquidOral	Westminster Pharmaceuticals, LLC	69367-398
Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	AptaPharma Inc.	76281-604
Cough Dropsmenthol	Menthol 5.8 mg/1	PastilleOral	Topco Associates LLC	76162-016

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Theraflu Severe Cold Relief Nighttime Soft Chews (Acetaminophen, diphenhydramine hcl) NDC 0067-0112