ADVIL PM diphenhydramine citrate and ibuprofen 38 mg; 200 mg Tablet, Coated
by Haleon US Holdings LLC · 3000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH
NDC 00573-0164-91
🏷️ FDA NDC (as labeled)
0573-0164-91
billing pads the labeler segment with a zero
This package
Contains2 tablet, coated in 1 pouch
Pack sizes21 compare ↓
Also comes in:
2 tablets 00573-0164-05
2 tablets 00573-0164-12
2 tablets 00573-0164-14
2 tablets 00573-0164-55
4 tablets 00573-0164-04
8 tablets 00573-0164-08
8 tablets 00573-0164-09
20 tablets 00573-0164-20
30 tablets 00573-0164-21
40 tablets 00573-0164-30
50 tablets 00573-0164-32
50 tablets 00573-0164-33
80 tablets 00573-0164-40
100 tablets 00573-0164-41
120 tablets 00573-0164-43
120 tablets 00573-0164-65
140 tablets 00573-0164-44
180 tablets 00573-0164-45
180 tablets 00573-0164-46
200 tablets 00573-0164-49
OTC
Brand
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
0573-0164-91
Product NDC
0573-0164
11-digit billing NDC
00573016491
RxCUI
895664
UNII
4OD433S209, WK2XYI10QM
Application #
NDA021394
SPL Set ID
658fc201-47c9-6a6d-8af9-6208298d43b4
Established class (EPC)
Nonsteroidal Anti-inflammatory Drug
Mechanism of action
Cyclooxygenase Inhibitors
Chemical class
Anti-Inflammatory Agents, Non-Steroidal
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2005-12-21
Route
ORAL
Dosage form
TABLET, COATED
Substance
DIPHENHYDRAMINE CITRATE; IBUPROFEN
GPI-14
60309902400320
GPI class
Advil PM
GCN Seq No
062493
GCN
98268
HICL code
034634
Ingredient (HICL)
Ibuprofen/Diphenhydramine Cit
HIC1 code
S
Therapeutic class — broad (HIC1)
Locomotor System
HIC2 code
S2
Therapeutic class — intermediate (HIC2)
Drugs Acting Principally On Joints
HIC3 code
S2S
Therapeutic class — specific (HIC3)
Analgesic,Nsaid-1St Gen.antihistamine,Sedative Cmb
AHFS code
04:04.04.00
AHFS class
Ethanolamine Derivatives
FDB label name
ADVIL PM 200-38 MG CAPLET
FDB brand name
Advil Pm
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0573-0164-91 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00573-0164-91. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Pharmacologic class
Histamine-1 Receptor Antagonist
Drug family (ATC)
Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works
Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerHaleon US Holdings LLC
Application holderHALEON US HOLDINGS LLC
FDA applicationNDA021394 (NDA)
Labeler code00573
First marketedDec 2005
Product typeHuman Otc Drug
Portfolio404 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name ADVIL PM 200-38 MG CAPLET Ingredient Ibuprofen/Diphenhydramine Cit
📖 What it is MedlinePlus · NLM
Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- No — this product is specifically for nights when you have both minor pain AND trouble sleeping at the same time. It's not meant to be used as a plain sleep aid. If you're struggli...
- What exactly is this medicine for — can I just take it to help me sleep?
- Take 2 capsules or caplets at bedtime — whichever form your product comes in. Don't take more than that in 24 hours. If it bothers your stomach, go ahead and take it with food or a...
- How do I take it, and is it okay to take with food?
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about diphenhydramine citrate and ibuprofen?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
blue
ShapeOval
ImprintAdvil;PM
Size15 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 776XM7047L
Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
-
UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
-
UNII R8WTH25YS2
Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII VH2XOU12IE
Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
-
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
16 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescalcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| good neighbor pharmacy ibuprofen pm 38 mg/1; 200 mg 46122-0708-41 | Amerisource | 80 tablets | $0.122 | — | Discontinued | — |
| Leader Ibuprofen PM 38 mg/1; 200 mg 70000-0157-01 | Cardinal | 40 tablets | $0.125 | — | Availability likely | — |
| good sense ibuprofen pm 38 mg/1; 200 mg 00113-0050-58 | L. | 40 tablets | $0.131 | — | Availability likely | — |
| foster and thrive ibuprofen pm 38 mg/1; 200 mg 70677-1131-01 | Strategic | 40 tablets | $0.131 | — | Availability likely | — |
| Ibuprofen PM 38 mg/1; 200 mg 00363-0050-27 | Walgreen | 80 tablets | — | — | FDA listed | — |
| Advil Pm 38 mg/1; 200 mgthis 00573-0164-91 | Haleon | 2 tablets | — | — | FDA listed | — |
| up and up ibuprofen pm 38 mg/1; 200 mg 11673-0050-58 | Target | 40 tablets | — | — | FDA listed | — |
| ibuprofen pm 38 mg/1; 200 mg 11822-0050-01 | Rite | 80 tablets | — | — | Discontinued | — |
| Ibuprofen PM 200 mg/1; 38 mg 21130-0056-40 | Safeway, | 40 tablets | — | — | FDA listed | — |
| Ibuprofen and Diphenhydramine Citrate 200 mg/1; 38 mg 21130-0228-12 | Better | 40 tablets | — | — | FDA listed | — |
| Signature Care Ibuprofen PM 38 mg/1; 200 mg 21130-0283-27 | Safeway | 80 tablets | — | — | Discontinued | — |
| Ibuprofen Pm 38 mg/1; 200 mg 21130-0623-76 | Safeway | 120 tablets | — | — | FDA listed | — |
| ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 38 mg/1; 200 mg 29485-6533-04 | Lil | 2 tablets | — | — | FDA listed | — |
| ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 38 mg/1; 200 mg 29485-7008-03 | Lil | 2 tablets | — | — | FDA listed | — |
| ibuprofen pm 38 mg/1; 200 mg 30142-0050-27 | Kroger | 80 tablets | — | — | FDA listed | — |
| Ibuprofen PM 200 mg/1; 38 mg 30142-0278-80 | KROGER | 80 tablets | — | — | FDA listed | — |
| Topcare Ibuprofen PM 38 mg/1; 200 mg 36800-0050-27 | Topco | 80 tablets | — | — | FDA listed | — |
| ibuprofen pm 38 mg/1; 200 mg 37808-0703-60 | H | 20 tablets | — | — | FDA listed | — |
| equaline ibuprofen pm 38 mg/1; 200 mg 41163-0050-27 | United | 80 tablets | — | — | FDA listed | — |
| Ibuprofen PM 38 mg/1; 200 mg 41250-0050-27 | Meijer | 80 tablets | — | — | Discontinued | — |
| Care One Ibuprofen PM 38 mg/1; 200 mg 41520-0050-27 | American | 80 tablets | — | — | FDA listed | — |
| ibuprofen pm 38 mg/1; 200 mg 42507-0050-27 | HyVee | 80 tablets | — | — | FDA listed | — |
| equate ibuprofen pm 38 mg/1; 200 mg 49035-0699-27 | Wal-Mart | 80 tablets | — | — | FDA listed | — |
| Motrin PM 200 mg/1; 38 mg 50580-0563-20 | Kenvue | 20 tablets | — | — | FDA listed | — |
| Ibuprofen and Diphenhydramine Citrate 200 mg/1; 38 mg 55111-0565-05 | Dr. | 500 tablets | — | — | FDA listed | — |
| Exchange Select Ibuprofen PM 38 mg/1; 200 mg 55301-0050-60 | Army | 20 tablets | — | — | FDA listed | — |
| Ibuprofen PM 200 mg/1; 38 mg 55319-0197-20 | Family | 20 tablets | — | — | FDA listed | — |
| dg health Ibuprofen pm 38 mg/1; 200 mg 55910-0050-27 | Dolgencorp | 80 tablets | — | — | FDA listed | — |
| Ibuprofen and Diphenhydramine Citrate 200 mg/1; 38 mg 58602-0867-09 | Aurohealth | 30 tablets | — | — | FDA listed | — |
| ibuprofen pm 38 mg/1; 200 mg 59779-0050-27 | CVS | 80 tablets | — | — | FDA listed | — |
| Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg 200 mg/1; 38 mg 63548-0197-02 | PLD | 20 tablets | — | — | FDA listed | — |
| Advil PM, TRAVEL BASIX 200 mg/1; 38 mg 66715-6433-02 | Lil' | 2 tablets | — | — | FDA listed | — |
| Advil PM, CVP HEALTH 200 mg/1; 38 mg 66715-6533-02 | Lil' | 2 tablets | — | — | FDA listed | — |
| Advil PM 200 mg/1; 38 mg 66715-9633-03 | Lil' | 2 tablets | — | — | FDA listed | — |
| Advil PM 200 mg/1; 38 mg 66715-9733-02 | Lil' | 2 tablets | — | — | FDA listed | — |
| Advil PM 38 mg/1; 200 mg 67751-0147-01 | Navajo | 2 tablets | — | — | FDA listed | — |
| Ibuprofen PM 200 mg/1; 38 mg 69607-1970-01 | WR | 120 tablets | — | — | FDA listed | — |
| basic care ibuprofen pm 38 mg/1; 200 mg 72288-0050-60 | Amazon.com | 20 tablets | — | — | FDA listed | — |
| Amazon Basic Care Ibuprofen Pm 200 mg/1; 38 mg 72288-0061-77 | Amazon.com | 120 tablets | — | — | FDA listed | — |
| Ibuprofen PM 200 mg/1; 38 mg 79903-0186-20 | WALMART | 20 tablets | — | — | FDA listed | — |
| Advil Pm 38 mg/1; 200 mg 85237-1784-01 | Select | 2 tablets | — | — | FDA listed | — |
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2005
On the market since
Dec 2005
📍
2026
Currently FDA-listed
21 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Advil PM (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 32%
Female · 68%
Unknown · 1%
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00573-0164-04 | 4 TABLET, COATED in 1 POUCH (0573-0164-04) | 2005-12-21 | Active |
| 00573-0164-05 | 2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-08 | 1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL | 2017-03-17 | Active |
| 00573-0164-09 | 8 TABLET, COATED in 1 VIAL (0573-0164-09) | 2017-03-17 | Active |
| 00573-0164-12 | 6 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCH | 2005-12-21 | Active |
| 00573-0164-14 | 2 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCH | 2005-12-21 | Active |
| 00573-0164-20 | 1 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-21 | 1 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-30 | 1 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-32 | 1 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-33 | 1 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-40 | 1 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-41 | 1 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-43 | 1 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-44 | 1 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-45 | 1 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-46 | 1 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-49 | 1 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLE | 2005-12-21 | Active |
| 00573-0164-55 | 50 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCH | 2005-12-21 | Active |
| 00573-0164-65 | 120 TABLET, COATED in 1 BOTTLE (0573-0164-65) | 2016-09-30 | Active |
| 00573-0164-91 You're viewing this | 3000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH | 2005-12-21 | Active |
Pack size FAQ
What quantity is in NDC 00573-0164-91?
NDC 00573-0164-91 is listed by the FDA — 3000 pouch in 1 box / 2 tablet, coated in 1 pouch.
What NDC number is used to bill for this package of ADVIL PM diphenhydramine citrate and ibuprofen 38 mg; 200 mg Tablet, Coated?
Bill NDC 00573-0164-91 — the 11-digit billing format is 00573016491. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0573-0164-91, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00573-0164-91, written without dashes as 00573016491. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00573-0164-91, the first segment (00573) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (0164) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (91) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 20 other package presentations of this same product, including 2 tablets (00573-0164-05), 2 tablets (00573-0164-12), 2 tablets (00573-0164-14). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Haleon US Holdings LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
⏱️ Dosage and Administration ▾
Directions do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours
⚠️ Warnings ▾
Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night's sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid under a doctor's care for any continuing medical illness taking any other antihistamines taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks.
Insomnia may be a symptom of a serious underlying medical illness. redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active ingredients (in each caplet) Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
🧪 Inactive Ingredients ▾
Inactive ingredients calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
🎯 Purpose ▾
Purposes Nighttime sleep-aid Pain reliever
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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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