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LITTLE REMEDIES NEW BABY ESSENTIALS ACETAMINOPHEN, SIMETHICONE, ZINC OXIDE Kit

by Medtech Products Inc. · 1 KIT in 1 CARTON (63029-615-01) * 57 g in 1 TUBE * 59 mL in 1 BOTTLE * 15 mL in 1 BOTTLE * 30 mL in 1 BOTTLE * 59 mL in 1 BOTTLE
NDC 63029-0615-01
🏷️ FDA NDC (as labeled) 63029-615-01 billing pads the product segment with a zero
OTC 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 63029-615-01
Product NDC 63029-615
11-digit billing NDC 63029061501
RxCUI 198857, 307675
SPL Set ID 4b1b7294-aca6-45fa-a008-c1869131b2a3
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-02-15
Dosage form KIT
Why two NDCs? The FDA registers this code as 63029-615-01 — 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 → 63029-0615-01. 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

LabelerMedtech Products Inc.
Labeler code63029
First marketedFeb 2017
Product typeHuman Otc Drug
Portfolio57 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

🧪 What is this product?

This is a kit product containing three active ingredients without an approved FDA application. Acetaminophen is commonly used to reduce fever and relieve minor aches and pain. Simethicone is typically used to help relieve gas and bloating. Zinc oxide is commonly used in diaper rash creams and skin barrier products. This kit appears designed to address multiple common concerns in infant care.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

From the label’s inactive-ingredient sectionbenzoic acid, carboxymethylcellulose, glycerin, natural grape flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum FOR DIAPER RASH BOUDREAUX’S BUTT PASTE ®  Diaper Rash Ointment Drug Facts Active ingredient Purpose Zinc oxide, 16%...................................................Skin protectant Uses Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness Warnings For external use only When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens or does not improve after 7 days Keep out of the reach of children to prevent accidental ingestion If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately Directions Change wet and soiled diaper immediately Cleanse the diaper area and allow to dry Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime Other i nformation Store at room temperature 20°- 27°C (68°- 80°F) Remove seal from jar before use Use with infants, children and adults Will stain clothing and fabric Inactive ingredients castor oil, mineral oil, paraffin, peruvian balsam, white petrolatum Questions? 1-855-785-2888 www.buttpaste.com FOR TUMMYS TM GAS RELIEF DROPS   Simethicone / Antigas Drug Facts carmellose sodium,citric acid, microcrystalline cellulose, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum FOR TUMMYS TM GRIPE WATER Supplement Facts Serving Size: 5 mL Servings per Container: about 12 Amount per Serving% Daily Value Zingiber officinale (Ginger) Root Extract       5 mg       † Foeniculum vulgare (Fennel) Seed Extract       4mg † †Daily Value not established water, sodium chloride, glycerin, sodium benzoate, benzoic acid

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 systemPer eachPer 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Little Remedies New Baby Essentialsthis 63029-0615-01 Medtech 1 kit — — 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 years listed
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63029-0615-01 You're viewing this 1 KIT in 1 CARTON (63029-615-01) * 57 g in 1 TUBE * 59 mL in 1 BOTTLE * 15 mL in 1 BOTTLE * 30 mL in 1 BOTTLE * 59 mL in 1 BOTTLE 2017-02-15 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application Kit / multi-component package

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 — Not published for this NDC No photo available yet for this listing.
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 "Unapproved Drug Other". 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 63029-615-01, 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: 63029-0615-01, written without dashes as 63029061501. 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 63029-0615-01, the first segment (63029) is the labeler code FDA assigned to Medtech Products Inc.; the middle segment (0615) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Medtech Products Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medtech Products 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 76 words ▾

Uses Temporarily: reduces fever relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.

Uses Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food

Uses –Helps loosen mucus secretions to aid aspiration and removal from nose and sinuses, allowing for easier breathing. For infants this can be assisted with the use of our specially designed “Soft Tip” Nasal Aspirator.

⏱️ Dosage and Administration ~2 min read ▾

Directions This product does not contain directions or complete warnings for adult use. Shake well before using Find the right dose on the chart on the chart below. If possible, use weight to determine dose; otherwise, use age.

Only use the enclosed AccuSafe® syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child. Remove cap, insert syringe to flow restrictor and invert bottle Pull back syringe until filled to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek) If needed, repeat dose every 4 hours while symptoms last Do not give more than 5 times in any 24-hour period (see overdose warning) Do not give more than 5 days unless directed by a doctor Replace cap tightly to maintain child resistance mL = milliliter Weight (lbs) Age (yrs) Dose (mL) Under 24 under 2 Ask a doctor 24-35 2-3 5 mL

Directions ■ shake well before using ■ only use enclosed syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek ■ all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day. ■ dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids ■ for best results, clean syringe after each use and replace original cap If possible, use weight to determine dose; otherwise use age. mL = milliliters Age (yrs) Weight (lbs) Dose Newborns & Infants under 2 years under 24 0.3 mL Children 2 years and over 24 and over 0.6 mL

Directions (For nasal use only) ▪ Infants: 2 to 6 drops in each nostril as often as needed or as directed by your doctor. ▪Children: 2 to 6 sprays or drops into each nostril as often as needed or as directed by a doctor. Store at 20°-25°C (68°-77°F). See bottle for lot and expiration date.

⚠️ Warnings ~1 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes ▪ more than 5 doses in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen. Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash. If a skin reaction occurs, stop use and seek medical help right away.

Do not use with any other products containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doc tor before use if the child has liver disease.

Ask a doctor or pharma cist before use if the child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning ) Stop use and ask a doctor if new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present. These could be signs of a serious condition.

Keep out of reach of children. Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Prompt medical attention is critical even if you do not notice any signs or symptoms.

Warnings Keep out of reach of children.

Warnings Keep out of reach of children. ▪ The use of this dispenser by more than one person may spread infection. ▪ Wipe nozzle clean after each use.

🧪 Active Ingredient 23 words ▾

Active ingredient (in each 5 mL) Acetaminophen 160 mg

Active ingredient (in each 0.3 mL) Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg

🧪 Inactive Ingredients ~1 min read ▾

Inactive ingredients benzoic acid, carboxymethylcellulose, glycerin, natural grape flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum FOR DIAPER RASH BOUDREAUX’S BUTT PASTE ® Diaper Rash Ointment Drug Facts Active ingredient Purpose Zinc oxide, 16%...................................................Skin protectant Uses Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness Warnings For external use only When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens or does not improve after 7 days Keep out of the reach of children to prevent accidental ingestion If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately Directions Change wet and soiled diaper immediately Cleanse the diaper area and allow to dry Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime Other i nformation Store at room temperature 20°- 27°C (68°- 80°F) Remove seal from jar before use Use with infants, children and adults Will stain clothing and fabric Inactive ingredients castor oil, mineral oil, paraffin, peruvian balsam, white petrolatum Questions ?

1-855-785-2888 www.buttpaste.com FOR TUMMYS TM GAS RELIEF DROPS Simethicone / Antigas Drug Facts

Inactive ingredients carmellose sodium,citric acid, microcrystalline cellulose, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum FOR TUMMYS TM GRIPE WATER Supplement Facts Serving Size: 5 mL Servings per Container: about 12 Amount per Serving % Daily Value Zingiber officinale (Ginger) Root Extract 5 mg † Foeniculum vulgare (Fennel) Seed Extract 4mg † †Daily Value not established

Ing r edients : water, sodium chloride, glycerin, sodium benzoate, benzoic acid

🎯 Purpose 8 words ▾

Purpose Pain reliever / Fever reducer

Purpose Antigas

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63029-0610-01 · Medtech 63029-0621-08 · Medtech →
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.