Rompe Pechito Allergy for Kids Diphenhydramine HCl 12.5 mg/5mL Syrup
by Efficient Laboratories, Inc. · 1 BOTTLE in 1 CARTON (58593-006-04) / 118 mL in 1 BOTTLE
NDC 58593-0006-04
🏷️ FDA NDC (as labeled)
58593-006-04
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Sep 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)
58593-006-04
Product NDC
58593-006
11-digit billing NDC
58593000604
Application #
M012
SPL Set ID
5b99ac95-bc71-8431-e063-6294a90a5a36
Established class (EPC)
Histamine-1 Receptor Antagonist
Mechanism of action
Histamine H1 Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-09-01
Route
ORAL
Dosage form
SYRUP
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 58593-006-04 — a 5-3-2 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 product segment → 58593-0006-04. 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.
🏭 Manufacturer & labeler
LabelerEfficient Laboratories, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code58593
First marketedSep 2026
Product typeHuman Otc Drug
Portfolio3 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
📗 Our plain-language guide HelloPharmacist
- Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
- What exactly does diphenhydramine treat?
- Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
- It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
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 HCl?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII Y9H1V576FH
Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
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UNII 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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UNII 89DS0H96TB
Zinc sulfate is a mineral salt used in medications as a source of zinc. It functions as an active nutritional ingredient in some formulations and may also serve as a buffer or pH stabilizer in tablets and liquids.
12 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesanhydrous citric acid, elderberry fruit extract, flavor, glycerin, honey, maltodextrin, methylparaben, potassium sorbate, propylparaben, propylene glycol, purified water, sodium chloride, sucralose and zinc sulfate
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 mL | 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 |
|---|---|---|---|---|---|---|
| Childrens Allergy 12.5 mg/5mL 63868-0823-54 | QUALITY | 1 bottle | $0.016 | — | FDA listed | — |
| Diphenhydramine HCl 12.5 mg/5mL 00904-6985-16 | Major | 473 ml | $0.017 | — | Availability likely | — |
| Allergy Relief 12.5 mg/5mL 54859-0811-16 | LLORENS | 473 ml | $0.017 | — | Availability likely | — |
| Allergy Relief Childrens 12.5 mg/5mL 00904-7533-15 | Major | 473 ml | $0.017 | — | Availability likely | — |
| Childrens Allergy Relief Dye Free 12.5 mg/5mL 70000-0693-01 | CARDINAL | 1 bottle | $0.018 | — | Availability likely | — |
| Good NeighborChildrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 46122-0793-29 | AMERISOURCE | 1 bottle | $0.019 | — | Availability likely | — |
| Childrens Allergy Relief 12.5 mg/5mL 70000-0701-01 | Cardinal | 1 bottle | $0.019 | — | Availability likely | — |
| good sense allergy 12.5 mg/5mL 00113-0379-26 | L. | 1 bottle | $0.019 | — | Availability likely | — |
| leader childrens allergy relief 12.5 mg/5mL 70000-0474-01 | Cardinal | 1 bottle | $0.019 | — | Availability likely | — |
| Foster and Thrive Childrens Allergy Relief 12.5 mg/5mL 70677-1012-01 | Strategic | 1 bottle | $0.020 | — | Availability likely | — |
| Quality Choice Dye Free Cherry Childrens Allergy Relief 12.5 mg/5mL 83324-0016-04 | Chain | 1 bottle | $0.027 | — | FDA listed | — |
| children allergy relief dye free cherry 12.5 mg/5mL 50090-6163-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Diphenhydramine HCl 12.5 mg/5mL 50090-6541-00 | A-S | 118 ml | — | — | FDA listed | — |
| OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution 12.5 mg/5mL 87078-0411-52 | MEDWISE | 12 pouches | — | — | FDA listed | — |
| equaline allergy 12.5 mg/5mL 41163-0379-26 | United | 1 bottle | — | — | FDA listed | — |
| allergy 12.5 mg/5mL 42507-0379-26 | HyVee | 1 bottle | — | — | FDA listed | — |
| Allergy Relief 12.5 mg/5mL 55319-0918-36 | Family | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Childrens 12.5 mg/5mL 79903-0368-04 | WALMART | 1 bottle | — | — | FDA listed | — |
| Nighttime Cold and Cough 12.5 mg/5mL 82673-0191-04 | KinderFarms, | 1 bottle | — | — | FDA listed | — |
| Childrens Dye Free Allergy Relief 12.5 mg/5mL 11822-0918-01 | Rite | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Childrens 12.5 mg/5mL 50844-0015-19 | L.N.K. | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Childrens 12.5 mg/5mL 51316-0180-19 | CVS | 1 bottle | — | — | FDA listed | — |
| Allergy Childrens 12.5 mg/5mL 55910-0124-36 | DOLGENCORP, | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy 12.5 mg/5mL 69676-0074-09 | Genexa | 1 bottle | — | — | FDA listed | — |
| Kosher Meds Childrens Allergy Relief 12.5 mg/5mL 82179-0004-04 | Mollec | 1 bottle | — | — | FDA listed | — |
| allergy relief childrens 12.5 mg/5mL 59779-0874-26 | CVS | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy Relief 12.5 mg/5mL 00363-8018-36 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Kids Allergy 12.5 mg/5mL 69676-0039-09 | Genexa | 1 bottle | — | — | FDA listed | — |
| Max Allergy Kids 12.5 mg/5mL 71399-0023-04 | Akron | 118 ml | — | — | FDA listed | — |
| Diphenhydramine HCL STRAWBERRY FLAVOR 12.5 mg/5mL 71800-0058-19 | Innovida | 119 ml | — | — | FDA listed | — |
| Puregen Labs Allergy Relief 12.5 mg/5mL 80513-0201-16 | Advanced | 473 ml | — | — | FDA listed | — |
| Geri Dryl 12.5 mg/5mL 83939-0007-01 | VERITYRX, | 5 ml | — | — | FDA listed | — |
| OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) 12.5 mg/5mL 87078-0421-52 | MEDWISE | 12 pouches | — | — | FDA listed | — |
| Childrens Allergy Relief 12.5 mg/5mL 11822-0379-00 | Rite | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Childrens 12.5 mg/5mL 50090-7824-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy 12.5 mg/5mL 63941-0292-04 | Best | 1 bottle | — | — | FDA listed | — |
| Children Allergy Relief Bubblegum flavor 12.5 mg/5mL 11673-0832-04 | TARGET | 1 bottle | — | — | FDA listed | — |
| childrens allergy relief dye-free 12.5 mg/5mL 11673-0918-36 | Target | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy Relief 12.5 mg/5mL 30142-0404-26 | Kroger | 1 bottle | — | — | FDA listed | — |
| Allergy 12.5 mg/5mL 37808-0379-26 | H | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Childrens 12.5 mg/5mL 55319-0315-36 | Family | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy 12.5 mg/5mL 56062-0379-26 | Publix | 1 bottle | — | — | FDA listed | — |
| Childrens Allergy Relief 12.5 mg/5mL 79903-0411-04 | WALMART | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Childrens 12.5 mg/5mL 83324-0326-04 | Chain | 1 bottle | — | — | FDA listed | — |
| good sense allergy 12.5 mg/5mL 68071-3734-04 | NuCare | 1 bottle | — | — | FDA listed | — |
| Diphenhydramine HCl 12.5 mg/5mL 68788-8274-01 | Preferred | 118 ml | — | — | FDA listed | — |
| Childrens Allergy Relief 12.5 mg/5mL 68998-0505-24 | Marc | 118 ml | — | — | FDA listed | — |
| Allergy Relief 12.5 mg/5mL 69256-0292-08 | Harris | 1 bottle | — | — | Discontinued | — |
| Childrens Allergy Relief 12.5 mg/5mL 69842-0719-19 | CVS | 1 bottle | — | — | FDA listed | — |
| Diphenhydramine HCL 12.5 mg/5mL 84447-0103-01 | Belleview | 200000 ml | — | — | FDA listed | — |
| CareOne Childrens Allergy Relief 12.5 mg/5mL 41520-0632-26 | American | 1 bottle | — | — | FDA listed | — |
| Allergy Relief Childrens 12.5 mg/5mL 51316-0150-19 | CVS | 1 bottle | — | — | FDA listed | — |
| Best Choice Childrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 63941-0710-04 | BEST | 1 bottle | — | — | FDA listed | — |
| Allergy Relief childrens 12.5 mg/5mL 79903-0175-08 | WALMART | 1 bottle | — | — | FDA listed | — |
| Childrens Dye Free Allergy Relief 12.5 mg/5mL 21130-0563-05 | BETTER | 1 bottle | — | — | Discontinued | — |
| Meijer Childrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 41250-0710-08 | MEIJER | 1 bottle | — | — | FDA listed | — |
| Allergy Relief 12.5 mg/5mL 54859-0837-04 | LLORENS | 118 ml | — | — | FDA listed | — |
| Dr Kids Allergy Relief 12.5 mg/5mL 73282-2521-01 | CalmCo | 24 vials | — | — | FDA listed | — |
| Geri Dryl 12.5 mg/5mL 57896-0980-16 | GERI-CARE | 473 ml | — | — | FDA listed | — |
| basic care childrens allergy relief 12.5 mg/5mL 72288-0379-26 | Amazon.com | 1 bottle | — | — | FDA listed | — |
| Rompe Pechito Allergy for Kids 12.5 mg/5mLthis 58593-0006-04 | Efficient | 1 bottle | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Diphenhydramine HCl (matched by generic name) — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diphenhydramine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$374.3K
Claims incl. refills
20.3K
Beneficiaries
11.2K
Spend / beneficiary
$33.36
Spend / claim
$18.44
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58593-0006-04 You're viewing this | 1 BOTTLE in 1 CARTON (58593-006-04) / 118 mL in 1 BOTTLE | 2026-09-01 | Active |
🧭 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
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 58593-006-04, 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: 58593-0006-04, written without dashes as 58593000604. 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 58593-0006-04, the first segment (58593) is the labeler code FDA assigned to Efficient Laboratories, Inc.; the middle segment (0006) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Efficient Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Efficient Laboratories, Inc. 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.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.