Over-the-counter drug · OTC MONOGRAPH DRUG

Preparation H (Phenylephrine hydrochloride) NDC 0573-1378

Phenylephrine hydrochloride 6.25 mg/1 · Suppository · Rectal · Haleon US Holdings LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)0573-1378Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00573-1378Add 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 NDC11-digit (billing)PackageCopy
0573-1378-000057313780048 BLISTER PACK in 1 CARTON (0573-1378-00) / 1 SUPPOSITORY in 1 BLISTER PACKMarketed from Dec 16, 2022
0573-1378-010057313780112 BLISTER PACK in 1 CARTON (0573-1378-01) / 1 SUPPOSITORY in 1 BLISTER PACKMarketed from Dec 16, 2022
0573-1378-060057313780624 BLISTER PACK in 1 CARTON (0573-1378-06) / 1 SUPPOSITORY in 1 BLISTER PACKMarketed from Dec 16, 2022

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)
Preparation H
Generic name (nonproprietary)
phenylephrine hydrochloride
Active ingredients
Phenylephrine hydrochloride — 6.25 mg/1
Dosage form
Suppository
Route
Rectal
Labeler
Haleon US Holdings LLCNDC labeler code 0573
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 015
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)
Identifiers
Product ID 0573-1378_331041bf-cde7-dceb-e063-6394a90a65e0SPL ID 331041bf-cde7-dceb-e063-6394a90a65e0SPL set ID 96d2e0e7-2de0-4660-9ffd-9edb2ad224d8UNII 04JA59TNSJ
Pharmacologic class
alpha-1 Adrenergic Agonist

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400573137800 followed by a unit qualifier and the quantity

Package 00573-1378-00. 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 helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0573-1378

What is NDC 0573-1378?
0573-1378 is the product NDC for Preparation H (phenylephrine hydrochloride), Phenylephrine hydrochloride 6.25 mg/1 suppository, listed with the FDA by Haleon US Holdings LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Preparation H (Phenylephrine hydrochloride).
What is the active ingredient?
Phenylephrine hydrochloride.
Who is the labeler?
Haleon US Holdings LLC, NDC labeler code 0573. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Preparation H?
5 other product NDCs are listed under this name. See all Preparation H 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 Preparation H NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Preparation Hphenylephrine hydrochloridePhenylephrine hydrochloride 6.25 mg/1SuppositoryRectalHaleon US Holdings LLC0573-291900573-2919-1200573-2919-2400573-2919-48
Preparation Hcocoa butter, phenylephrine hydrochloride, and witch hazel—KitHaleon US Holdings LLC0573-288400573-2884-12
Preparation Hmineral oil, petrolatum, phenylephrine hclPhenylephrine hydrochloride 2.5 mg/g + 2 more ingredientsOintmentTopicalHaleon US Holdings LLC0573-287100573-2871-0400573-2871-1000573-2871-20+4 more
Preparation Hcocoa butter, phenylephrine hydrochlorideCocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.25 mg/1SuppositoryRectalHaleon US Holdings LLC0573-2880—
Preparation Hcocoa butter, phenylephrine hydrochlorideCocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.25 mg/1SuppositoryRectalHaleon US Holdings LLC0573-2883—

Other NDCs under M 015

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

FDA NDC Directory listings under M 015
ProductStrengthForm · routeLabelerProduct NDC
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochlorideMineral oil 14 g/100g + 2 more ingredientsOintmentTopicalNantong Health & Beyond Hygienic Products Inc.43473-094
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochlorideMineral oil 14 g/100g + 2 more ingredientsOintmentTopicalUniversal Distribution Center LLC52000-438
5% Lidocaine 10g5% lidocaineLidocaine 5 g/100gCreamTopicalChongqing Mandongzi Technology Co., Ltd88002-001
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangzhou Haishi Biological Technology Co., Ltd.60771-0028
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangzhou Haishi Biological Technology Co., Ltd.60771-0029
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangdong Aimu Biological Technology Co., Ltd83566-615
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangzhou Haishi Biological Technology Co., Ltd.60771-0041
Adellina Lidocaine Numbing Cream Topical Anorectal CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangdong Aimu Biological Technology Co., Ltd83566-612
Adellina Lidocaine Numbing Cream Topical Anorectal CreamlidocaineLidocaine 5 g/100gCreamTopicalGuangdong Aimu Biological Technology Co., Ltd83566-614
ADVANCED NUMB Topical Anestheticlidocaine hydrochlorideLidocaine hydrochloride 50 mg/gCreamTopicalUber Scientific, LLC71131-052
AER Pre-moistened Witch Hazel Padwitch hazelWitch hazel 500 mg/mLSolutionRectal, TopicalBirchwood Laboratories LLC50289-3250
AER Traveler Toweletteaer travelerWitch hazel .5 g/1SolutionRectal, TopicalBirchwood Laboratories LLC50289-4200
AmericainebenzocaineBenzocaine 5.6 g/28gOintmentTopicalInsight Pharmaceuticals LLC63736-375
AnievaLClidocaineLidocaine .05 g/gCreamTopicalBlackstone Products, LLC87798-001
ANIXIKE Numbinglidocaine4% numbingLidocaine 4 g/100gCreamTopicalJiangxi Yudexi Pharmaceutical Co., LTD85248-166
Arlun LIDOCAINE Creamlidocaine creamLidocaine 5 g/100gCreamTopicalGuangzhou Jingliang Cosmetics Co., Ltd.87408-021
Assured Bikini Smooth CreamlidocaineLidocaine 2 g/100gCreamTopicalZhejiang Jingwei Pharmaceutical Co., Ltd.55621-011
Asteroidmenthol, petrolatum, zinc oxideMenthol .098 g/28g + 2 more ingredientsOintmentTopicalHEALTHTEX LIMITED84107-552
B-SURE Traveler Toweletteb-sure travelerWitch hazel .5 g/gSolutionRectal, TopicalBirchwood Laboratories LLC50289-9250
Barrier Protectant Creambarrier creamMenthol 1 mg/g; Zinc oxide 200 mg/gOintmentTopicalCardinal Health63517-003

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